Adapters Request Portal

As customer's complained in the case CN-629171,

https://rexis.lightning.force.com/lightning/r/CMPL123CME__Complaint__c/a305p000001UQSuAAO/view

We would like to request update COBASYN driver to fix the issue of patients results starting with letter "C" recognized by cobas infinity as QC results.

Bellow is the case description for your reference.

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>ISSUE DESCRIPTION:

The affiliate reported that the COBASYN driver version 3.1.0.18 treats all the results with sampleID starting with the letter “C” as quality results.

>ANALYSIS:

cobas ® infinity software can be configured to send/receive different types of information from/to external instruments. This can be done via the ICA (Instrument Connectivity Agent) module together with the different instrument drivers. Then, an instrument driver aims to determine which data is obtained from the message sent by the instrument, and how it is received. There are two ways to connect the laboratory instruments to cobas ® infinity: using CommServer or ICA. CommServer or Communication Server is a specific platform used to connect the instruments and infinity, which differs of the regular ICA drivers because the CommServer driver can be used to connect the same instrument to different LISs (Laboratory Information Systems).

Quality controls (QC) are performed daily in the laboratory to verify whether instruments operate correctly and produce reliable patient results. Each laboratory defines a range of results that are considered acceptable for each test and control. If QC results lie within this reference range, the analytical run is considered to be in control. cobas ® infinity has a module in charge of considering the different tests, reagents, and controls in order to verify if an analytical run is under the laboratory standards.

In this case, the affiliate reports that for all of the patients samples with sample ID starting with the letter “C”, COBASYN driver treats them as quality results and does not send them to LIS.

In the driver Release notes it is specified that that there is no special support for quality controls. A message is considered As Quality Controsl when any repetition of M record in M-7.3 equals “CO” and also when the sample ID begins with the “C” character.

If the customer requires that the patient samples starting with the “C” letter are treated as regular results instead of QC results, a change request should be performed to the International Product Manager (IPM).

>CAUSAL FACTOR / ROOT CAUSE:

Messages with Sample IDs starting with a “C” character are considered Quality Control

>SOLUTION / CONCLUSION:

Customer Allegation Substantiated: No

The allegation could not be verified as a software issue. If the customer requires that default messages are added to cobas infinity a change request should be performed to the IPM.

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