BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS TAQSCREEN MPX TEST

    MDR report key: 1832574 · Received September 13, 2010

    Report

    Report Number
    2243471-2010-00036
    Date Received
    September 13, 2010
    Date of Event
    August 6, 2010
    Report Date
    December 20, 2010
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZF
    PMA / PMN Number
    BL 125255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME AS THE INVESTIGATION INTO THIS ISSUE IS ONGOING. THE OUTCOME OF THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. NOTE: PRODUCT CODE MZF WAS SELECTED AS NO ALTERNATIVE / MORE APPLICABLE CODE IS AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED / UPDATED DATA: UPDATED TO INDICATE THAT THE DEVICE WAS EVALUATED BY THE MANUFACTURER. UPDATED TO REFLECT THE OUTCOME OF THE INVESTIGATION. MANUFACTURER NARRATIVE: COMPLAINT HISTORY ANALYSIS. THE INVESTIGATION INTO THIS ISSUE DETERMINED THE FOLLOWING: A PRODUCT NON-CONFORMANCE WAS NOT IDENTIFIED. THERE WAS NO INDICATION OF CROSS-CONTAMINATION IDENTIFIED. THERE WERE NO GROWTH CURVE ANOMALIES IDENTIFIED. NO RELATED COMPLAINT CASES WERE IDENTIFIED FROM THE COMPLAINT KIT LOT OR THE ISSUE OF DISCREPANT RESULTS BETWEEN COBAS TAQSCREEN MPX TEST RUNS. AN ANALYSIS OF THE DONOR SPECIMENS COULD NOT PERFORMED. ALTHOUGH REQUESTED, THE DONOR SPECIMENS WERE NOT MADE AVAILABLE TO ROCHE MOLECULAR SYSTEMS FOR INVESTIGATION. IT IS BELIEVED THAT THIS ISSUE WAS LIKELY THE RESULT OF A LOW-LEVEL INFECTION, WHICH UPON REPEAT TESTING GENERATED DISCREPANT RESULTS (POISSON EFFECT). HOWEVER, AS NO DONOR MATERIEL WAS RETURNED FOR EVALUATION, FURTHER ANALYSIS OF THIS HYPOTHESIS COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, THERE WAS NO PRODUCT NON-CONFORMANCE OR MALFUNCTION IDENTIFIED WITH THE COMPLAINT KIT LOT OR THE COBAS TAQSCREEN MPX TEST. FURTHERMORE, THIS ISSUE DID NOT LEAD TO THE RELEASE OF INFECTED DONOR MATERIAL; A POSITIVE RESULT WOULD LEAD TO A DONATION BEING REJECTED, ESPECIALLY WHEN ACCOMPANIED BY A (B)(6) RESULT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) REPORTED THAT, FOR THE COBAS TAQSCREEN MPX TEST, THE PRIMARY POOL OF (B)(6); HOWEVER, RESOLUTION TESTING (INDIVIDUAL SAMPLE TESTING) WAS (B)(6). THE PRODUCT LABELING INDICATES THAT, IF ALL INDIVIDUAL DONOR SPECIMENS IN THE (B)(6) POOL TEST (B)(6), THE SPECIMENS IN THAT POOL ARE ALL REPORTED AS "(B)(6)." HOWEVER, DUE TO THE DISCREPANT RESULTS, THE CUSTOMER PERFORMED AN ADDITIONAL TEST WITH PRIMARY POOLS OF 1 AND IDENTIFIED A (B)(6) DONATION. NO SEROLOGY OR ALTERNATIVE NAT RESULTS WERE PROVIDED. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS TAQSCREEN MPX TEST HIV, HCV, HBV NUCLEIC ACID BLOOD SCREENING TEST MZF ROCHE MOLECULAR SYSTEMS M14697

    Patients

    Seq Age Sex Outcome Treatment
    1