BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16708808 · Received April 10, 2023

    Report

    Report Number
    1221359-2023-00608
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 26, 2023
    Report Date
    May 1, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. DEVICE DISCARDED; SINGLE-USE DEVICE.

    Additional Manufacturer Narrative · 0

    UPDATED DATA: A (4), (5), 6). ADDITIONAL DATA: NEW INFORMATION CAME IN ON 11APR2023, B (5): TESTING SAMPLE: CALIBRATED PIPETTE, ANTIBODY REACTIVE. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 206034 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 206034 AND DEVICE PART NUMBER 10732998/ LOT 204148. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED COMPLETE. ABBOTT DIAGNOSTICS SCARBOROUGH WILL CONTINUE TO MONITOR AND TREND FOR THIS REPORTED ISSUE. H3 OTHER TEXT : DEVICE DISCARDED; SINGLE-USE DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE WHICH DETERMINE HIV 1/2 AG/AB COMBO 25T ON TWO DIFFERENT DATES (B)(6) 2023 RESPECTIVELY. PER THE CUSTOMER, THREE PREGNANT FEMALES WERE TESTED POSITIVE WITH DETERMINE HIV 1/2 AG/AB COMBO 25T.CONFIRMATORY TESTS (GENIUS HIV 1 AND 2 SUPPLEMENTAL LATERAL FLOW ASSAY AND PCR) WERE PERFORMED AND GENERATED NEGATIVE RESULTS. THIS MFR. REPORT ADDRESSES PATIENT THREE (3) OF THREE (3) PATIENTS, TEST DATE ON (B)(6) 2023. THE PATIENTS WERE ADVISED TO TAKE A TRIPLE ANTIVIRAL MEDICATION TO TAKE HOME AFTER DELIVERY FOR 3 TO 4 DAYS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE WITH DETERMINE HIV 1/2 AG/AB COMBO 25T ON TWO DIFFERENT DATES (B)(6) 2023 AND (B)(6) 2023 RESPECTIVELY. PER THE CUSTOMER, THREE PREGNANT FEMALES WERE TESTED POSITIVE WITH DETERMINE HIV 1/2 AG/AB COMBO 25T.CONFIRMATORY TESTS (GENIUS HIV 1 AND 2 SUPPLEMENTAL LATERAL FLOW ASSAY AND PCR) WERE PERFORMED AND GENERATED NEGATIVE RESULTS. THIS MFR. REPORT ADDRESSES PATIENT THREE (3) OF THREE (3) PATIENTS, TEST DATE (B)(6) 2023. THE PATIENTS WERE ADVISED TO TAKE A TRIPLE ANTIVIRAL MEDICATION TO TAKE HOME AFTER DELIVERY FOR 3 TO 4 DAYS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798714 ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 206034 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female