BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19255979 · Received May 6, 2024

    Report

    Report Number
    1221359-2024-00374
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    March 1, 2024
    Report Date
    May 6, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    00811877011101
    PMA / PMN Number
    BP120037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G8: THE INITIAL REPORT FOR THIS SUBMISSION WAS INADVERTENTLY SUBMITTED UNDER MANUFACTURER REFERENCE NUMBER 3017662853-2024-00001. PLEASE DISREGARD THIS NUMBER. THE CORRECT REFERENCE NUMBER FOR THIS REPORT IS FOUND IN G8 ON THIS SUBMISSION. B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 820064 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 820064 AND TEST BASE PART NUMBER 10732998 / LOT 809186.THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 820064 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWENTY-THREE (23) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB TESTS PERFORMED ON UNKNOWN DATES WITH UNKNOWN SAMPLE TYPES. THIS MANUFACTURER'S REPORT ADDRESSES TEST NINE (9) OF TWENTY-THREE (23) AND IS ASSOCIATED WITH LOT# 820064 (QTY 6). THE CUSTOMER INDICATED THAT CONFIRMATION PCR TESTING WAS PERFORMED ON 1 OF THE 23 TESTS ON AN UNKNOWN DATE AND GENERATED A NEGATIVE RESULT. IT IS UNKNOWN IF CONFIRMATION OR REPEAT TESTING WAS PERFORMED FOR THE OTHER 22 RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388076 ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 820064 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male