BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HIV O PLUS

    MDR report key: 4213355 · Received October 30, 2014

    Report

    Report Number
    1415939-2014-00228
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 7, 2014
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4)..

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, 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. SPECIFICITY TESTING ON A REPRESENTATIVE LOT MET ALL SPECIFICATIONS. COMPLAINT DATA REVIEW BY LOT AND DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE THE SUSPECT MEDICAL DEVICE LOT IS UNKNOWN. HOWEVER, REVIEW OF THE PRISM METRICS FIELD DATA FROM JANUARY - AUGUST 2014 INDICATES THAT THE PRODUCT IS MEETING LABELING CLAIMS FOR CLINICAL SPECIFICITY. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, THE ASSAY PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) RESULTS THAT DO NOT CONFIRM FOR BLOOD DONORS ON THE PRISM ANALYZER. DATA WAS PROVIDED SHOWING THEIR REPEAT (B)(6) RATE IS BELOW (B)(6), BUT HIGHER THAN (B)(6) DATA. (B)(6) DONORS ARE (B)(6). PER THE PRISM (B)(4) PACKAGE INSERT: REPEATEDLY REACTIVE RESULTS INDICATE THE PRESENCE OF (B)(6) BY THE CRITERIA OF THE ABBOTT PRISM (B)(4) ASSAY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696740 PRISM HIV O PLUS HIV-1 AND HIV-2 ANTIBODIES MZF ABBOTT LABORATORIES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 LN 06A36-04, SN (B)(4)| PRISM ANALYZER:| PRISM ANALYZER:| LN 06A36-04, SN (B)(4)