BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 8645350 · Received May 28, 2019

    Report

    Report Number
    1221359-2019-00027
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    April 26, 2019
    Report Date
    May 28, 2019
    Manufacturer
    ALERE SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    10811877010293
    PMA / PMN Number
    BP120037-0
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ALERE (B)(4) ON RETAINED KIT LOTS 103698 AND 107842 (EXP 21 JULY 2020) WITH THE FOLLOWING INTERNAL SERUM/PLASMA CONTROL SAMPLES: (B)(6) SAMPLES. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOTS 103698 AND 107842 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS (B)(6) OR UNCONFIRMED (B)(6) RELATED TO LOT NUMBERS 103698 AND 107842 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ALERE (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 THE DEVICE LOTS ARE PERFORMING WITHIN LABELED CLAIMS.

    Description of Event or Problem · 1

    THIS REPORT REPRESENTS THE FIRST OF THREE CUSTOMER REPORTED (B)(6) RESULTS WITH THE ALERE DETERMINE HIV-1/2 AG/AB COMBO TEST ON SERUM SAMPLES FROM THREE (3) PATIENTS. (B)(6) ANTIBODY (AB) RESULTS WERE REPORTED ON A PREGNANT FEMALE PATIENT BEFORE DELIVERY. THE TEST WAS REPEATED ON TWO (2) DIFFERENT LOTS (LOT #: 103698; 107842), THREE (3) TIMES ON EACH LOT. CONFIRMATORY TESTING ON THE PREGNANT PATIENT WAS PERFORMED ON A 4TH GENERATION HIV CHEMILUMINESCENCE TEST AND REPORTED AS (B)(6). RNA VIRAL LOAD TESTING WAS PERFORMED AND REPORTED AS (B)(6). PRIOR TO CONFIRMATION OF TEST RESULTS, A CESAREAN SECTION WAS PERFORMED BASED ON THE (B)(6) RAPID HIV TEST GENERATED BY THE ALERE DETERMINE HIV-1/2 AG/AB COMBO. THE PATIENT RECEIVED (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439480 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV 1/2 AG/AB MZF ALERE SCARBOROUGH, INC. 103698 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| O