BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17391468 · Received July 25, 2023

    Report

    Report Number
    1221359-2023-01288
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    March 11, 2023
    Report Date
    August 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 213565 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 213565, TEST BASE PART NUMBER 10732998/ LOT 208366. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 213565 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. H10 H3 OTHER TEXT : DEVICE DISCARDED; SINGLE-USE DEVICE.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 213565 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 213565, TEST BASE PART NUMBER 10732998/ LOT 208366. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 213565 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. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION. DEVICE DISCARDED; SINGLE-USE DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE NEGATIVE RESULTS WITH THE ALERE DETERMINE HIV 1/2 AG/AB FOR MULTIPLE TESTS PERFORMED FROM (B)(6) 2023 TO (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF THREE (3). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH ALERE DETERMINE HIV 1/2 AG/AB PERFORMED ON (B)(6) 2023. REPEAT TESTING WAS PERFORMED ON (B)(6) 2023 AND (B)(6) 2023 AND GENERATED NEGATIVE RESULTS. CONFIRMATORY TESTING WAS SENT TO QUEST DIAGNOSTICS ON (B)(6) 2023 TO CONFIRM HIV RESULTS. RESULTS ARE UNKNOWN. ADDITIONAL TESTING WITH SIEMENS ATELLICA (REACTIVE COMBO) HIV WAS PERFORMED ON (B)(6) 2023 AND (B)(6) 2023 WHICH GENERATED POSITIVE RESULTS. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE NEGATIVE RESULTS WITH THE ALERE DETERMINE HIV 1/2 AG/AB FOR MULTIPLE TESTS PERFORMED FROM (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF THREE (3). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH ALERE DETERMINE HIV 1/2 AG/AB PERFORMED ON (B)(6) 2023. REPEAT TESTING WAS PERFORMED ON (B)(6) 2023 AND GENERATED NEGATIVE RESULTS. CONFIRMATORY TESTING WAS SENT TO QUEST DIAGNOSTICS ON (B)(6) 2023 TO CONFIRM HIV RESULTS. RESULTS ARE UNKNOWN. ADDITIONAL TESTING WITH SIEMENS ATELLICA (REACTIVE COMBO) HIV WAS PERFORMED ON (B)(6) 2023 WHICH GENERATED POSITIVE RESULTS. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343413 ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 213565 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male