BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T

    MDR report key: 16922421 · Received May 12, 2023

    Report

    Report Number
    1221359-2023-01125
    Event Type
    Malfunction
    Date Received
    May 12, 2023
    Date of Event
    May 5, 2023
    Report Date
    June 28, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    00811877011101
    PMA / PMN Number
    BP120037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 231618 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 7D2648/ LOT 231618 AND DEVICE PART NUMBER 10732998/ LOT 230461. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 231618 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION. H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. DEVICE DISCARDED, SINGLE USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SIX (6) FALSE POSITIVE RESULTS WITH DETERMINE HIV 1/2 AG/AB COMBO ON (B)(6) 2023 USING SERUM AND EDTA PLASMA SAMPLES WHICH WERE ADDED TO THE TESTS USING A PIPETTE. THIS MFR. REPORT ADDRESSES TEST THREE (3) OF SIX (6) TESTS, LOT NUMBER 231618 QUANTITY (3). ADDITIONAL TESTING WAS PERFORMED THE SAME DAY WITH A SIEMENS CENTAUR AND HOLOGIC PANTHER, BOTH OF WHICH GENERATED NEGATIVE RESULTS. THE PATIENT WAS IN LABOR AT THE TIME OF THE TESTING AND DELIVERED THE BABY WITHOUT INCIDENT. THE CUSTOMER REPORTED THAT THE PATIENT WAS TREATED WITH ANTIRETROVIRAL THERAPY. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SIX (6) FALSE POSITIVE RESULTS WITH DETERMINE HIV 1/2 AG/AB COMBO ON (B)(6) 2023 USING SERUM AND EDTA PLASMA SAMPLES WHICH WERE ADDED TO THE TESTS USING A PIPETTE. THIS MFR. REPORT ADDRESSES TEST THREE (3) OF SIX (6) TESTS, LOT NUMBER 231618 QUANTITY (3). ADDITIONAL TESTING WAS PERFORMED THE SAME DAY WITH A SIEMENS CENTAUR AND HOLOGIC PANTHER, BOTH OF WHICH GENERATED NEGATIVE RESULTS. THE PATIENT WAS IN LABOR AT THE TIME OF THE TESTING AND DELIVERED THE BABY WITHOUT INCIDENT. THE CUSTOMER REPORTED THAT THE PATIENT WAS TREATED WITH ANTIRETROVIRAL THERAPY. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357416 ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 231618 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female