BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 9403252 · Received December 3, 2019

    Report

    Report Number
    1221359-2019-00081
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 22, 2018
    Report Date
    January 21, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    10811877010293
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 101439 WITH THE FOLLOWING INTERNAL S/P CONTROL SAMPLES: HIV-1 POSITIVE, HIV-2 POSITIVE, P24 POSITIVE, AND HIV NEGATIVE. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 101439 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. THE RESULTS OBTAINED MAY POSSIBLY BE RELATED TO THE PATIENT SAMPLE. THE SAMPLE MAY HAVE CONTAINED SPECIFIC SUBSTANCES WHICH MAY HAVE AFFECTED THE RESULTS. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN LABELED CLAIMS.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED NINE (9) FALSE POSITIVE RESULTS WITH THE ALERE DETERMINE HIV-1/2 AG/AB COMBO TEST. NO PATIENT INFORMATION WAS PROVIDED UNTIL 26 DECEMBER 2019. THIS SUPPLEMENTAL REPORT REPRESENTS SIX (6) OF NINE (9). A CUSTOMER REPORTED A FALSE POSITIVE ANTIBODY (AB) RESULT (SAMPLE TYPE NOT OTHERWISE SPECIFIED) WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. CONFIRMATION TESTING WITH THE ABBOTT ARCHITECT WAS NEGATIVE/NONREACTIVE. THE PATIENT WAS REPORTED AS MALE. PATIENT TREATMENT AND OUTCOME ARE UNKNOWN. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. PER THE ALERE DETERMINE HIV-1/2 AG/AB COMBO PRODUCT INSERT: A REACTIVE RESULT USING ALERE DETERMINE HIV-1/2 AG/AB COMBO SUGGESTS THE PRESENCE OF HIV-1 P24 ANTIGEN AND/OR ANTIBODIES TO HIV-1 AND/OR HIV-2 IN THE SAMPLE. THE REACTIVE RESULT IS INTERPRETED AS PRELIMINARY POSITIVE FOR HIV-1 P24 ANTIGEN AND/OR ANTIBODIES TO HIV-1 AND/ORHIV-2. ALERE DETERMINE HIV-1/2 AG/AB COMBO IS INTENDED AS AID IN THE DIAGNOSIS OF INFECTION WITH HIV-1/2. REACTIVE TEST RESULTS SHOULD BE CONFIRMED BY ADDITIONAL TESTING USING OTHER TESTS. THE RISK WILL NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOTS: 106477, 107755, 108399, 109469, 110100, 109895, 108250, AND 108941 WITH THE FOLLOWING INTERNAL WHOLE BLOOD AND SERUM/PLASMA: (B)(6). ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOTS 106477, 107755, 108399, 109469, 110100, 109895, 108250, AND 108941 WERE REVIEWED. THESE LOTS MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE RELATED TO THE BELOW LOT NUMBERS SHOWED THAT THE COMPLAINT RATE IS: (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. THE RESULTS OBTAINED MAY POSSIBLY BE RELATED TO THE PATIENT SAMPLE. THE SAMPLE MAY HAVE CONTAINED SPECIFIC SUBSTANCES WHICH MAY HAVE AFFECTED THE RESULTS. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN LABELED CLAIMS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED NINE (9) (B)(6) RESULTS WITH THE ALERE DETERMINE HIV-1/2 AG/AB COMBO TEST. THIS REPORT REPRESENTS SIX (6) OF THE NINE (9) (B)(6) (AG/AB NOT SPECIFIED) ALERE DETERMINE HIV 1/2 AG/AB COMBO PATIENT RESULTS REPORTED FROM A CUSTOMER. CONFIRMATION TESTING (METHODOLOGY NOT OTHERWISE SPECIFIED) WAS NEGATIVE/NONREACTIVE. THE PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND OUTCOME WERE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196237 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV 1/2 AG/AB MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 101439 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR