BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM 6 CHANNEL ANALYZER

    MDR report key: 5307097 · Received December 17, 2015

    Report

    Report Number
    1628664-2015-00329
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Report Date
    January 19, 2016
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    MZA
    PMA / PMN Number
    BK970042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRISM REACTION TRAYS, LN 05A07-01, LOT 55001M500. PRISM HCV REAGENTS LN 06A52-48, LOT 54292LI00. PRISM HIV AG/AB COMBO REAGENTS LN 07G46-48, LOT 56728LI00. FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING AND SPECIFICITY TESTING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO PATIENT SAMPLE WAS AVAILABLE FOR RETURN, THEREFORE CLINICAL SPECIFICITY TESTING OF NEGATIVE CONTROL REPLICATES WAS PERFORMED USING IN-HOUSE RETAINED KITS STORED AT THE RECOMMENDED STORAGE CONDITION. ONE-HUNDRED FIVE (105) MEMBERS OF A HUMAN (B)(6) POPULATION PANEL WERE TESTED USING MATERIAL FROM INVENTORY OF PRISM HIV AG/AB COMBO, LOT 56728LI00, WITH PRISM REACTION TRAYS, LOT 55001M500. THE PANEL TESTING PRODUCED (B)(6) FOR ALL THE MEMBERS, WHICH INDICATES THAT THE PRODUCTS ARE MEETING EXPECTED SPECIFICITY REQUIREMENTS. SPECIFICITY TESTING MET ALL SPECIFICATIONS. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, THE ASSAY AND INSTRUMENT PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4). CONCOMITANT PRODUCTS: PRISM REACTION TRAYS LN (B)(4), LOT 55001M500; PRISM HCV REAGENTS LN (B)(4), LOT 54292LI00; PRISM HIV AG/AB COMBO REAGENTS LN (B)(4), LOT 56728LI00. AN EVALUATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED MULTIPLE FALSE REACTIVE HCV AND HIV AG/AB COMBO RESULTS ON THE PRISM ANALYZER. THERE WAS NO IMPACT TO PATIENT OR DONOR MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833692 PRISM 6 CHANNEL ANALYZER AUTOMATED IMMUNOASSAY ANALYZER MZA ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1