BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 9371664 · Received November 25, 2019

    Report

    Report Number
    1221359-2019-00074
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    October 31, 2019
    Report Date
    November 25, 2019
    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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(6) ON RETAINED KIT LOT 110834, 111287 AND 103972 WITH THE FOLLOWING INTERNAL SERUM/PLASMA AND WHOLE BLOOD QC PANEL SAMPLES: (B)(6). ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOTS 110834, 111287 AND 103972 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS (B)(6) RELATED TO LOT NUMBERS 110834, 111287 AND 103972 SHOWED THAT THE COMPLAINT RATE IS (B)(4), RESPECTIVELY. THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ABBOTT DIAGNOSTICS (B)(4) 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 (B)(6) AND CONFLICTING RESULTS BETWEEN TWO (2) SAMPLE TYPES FROM THE SAME PATIENT WITH THE ALERE DETERMINE (B)(6) COMBO. THE CUSTOMER REPORTED DUAL (B)(6) RESULTS ON A PLASMA SAMPLE WITH THE ALERE DETERMINE (B)(6) COMBO. THE SAMPLE WAS REPEATED ON TWO (2) ADDITIONAL LOTS (3 LOTS TOTAL), ALL GENERATING DUAL AG/AB (B)(6) RESULTS. THE CUSTOMER REPORTED (B)(6) RESULTS ON A SLIGHTLY HEMOLYZED SERUM SAMPLE FROM THE SAME PATIENT WITH THE ALERE DETERMINE (B)(6) COMBO. THE SAMPLE WAS REPEATED ON TWO (2) ADDITIONAL LOTS (3 LOTS TOTAL), ALL GENERATING AB (B)(6) RESULTS. CONFIRMATION TESTING ON THE ABBOTT ARCHITECT AND BIORAD GENIUS WAS (B)(6). THE PATIENT WAS REPORTED AS A PREGNANT FEMALE. THE PATIENT DID NOT RECEIVE ART BASED ON THE ALERE DETERMINE (B)(6) COMBO TEST RESULTS. ADDITIONALLY, NO SURGICAL PROCEDURES, INCLUDING CESAREAN SECTION, WERE PERFORMED BASED ON THE RESULTS. CONFLICTING RESULTS INDICATE A MALFUNCTION OF ONE OF THE TESTS AS IT IS EXPECTED THAT TESTING THE SAME PATIENT SAMPLE OR A SECOND SAMPLE FROM THE SAME PATIENT TESTED ON THE SAME DAY AS THE ORIGINAL SAMPLE WOULD RETURN THE SAME RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164782 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV 1/2 AG/AB MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 110834 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR