BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18698129 · Received February 13, 2024

    Report

    Report Number
    1221359-2024-00170
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    February 1, 2024
    Report Date
    April 14, 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
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 UDI : (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 788457 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 788457, TEST BASE PART NUMBER 10732998/ LOT 784540. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 788457 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    D4 UDI : (B)(4). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION. H3 OTHER TEXT : SINGLE-USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE ALERE DETERMINE HIV 1/2 AG/AB FOR TWO TESTS PERFORMED ON (B)(6) 2024 ON A SERUM SAMPLE. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE CUSTOMER STATED THE PATIENT CAME TO FACILITY DURING LABOR AND TEST WAS DONE BEFORE DELIVERY. ADDITIONAL TESTING WAS PERFORMED ON THE (B)(6) 2024 WITH A COBAS TEST (HIV ANTIGEN AND ANTIBODY) WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THE PATIENT WENT INTO DELIVERY AFTER THE NEGATIVE RESULT AND THERE WAS NO COMPLICATION. THERE WAS NO SURGICAL PROCEDURES AND PATIENT HAD A VAGINAL DELIVERY. THE CUSTOMER STATED THE PATIENT RECEIVED PROPHYLACTIC TREATMENT (ART) AND WAS ON SOME MEDICATIONS. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE ALERE DETERMINE HIV 1/2 AG/AB FOR TWO TESTS PERFORMED ON (B)(6) 2024 ON A SERUM SAMPLE. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE CUSTOMER STATED THE PATIENT CAME TO FACILITY DURING LABOR AND TEST WAS DONE BEFORE DELIVERY. ADDITIONAL TESTING WAS PERFORMED ON THE (B)(6) 2024 WITH A COBAS TEST (HIV ANTIGEN AND ANTIBODY) WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THE PATIENT WENT INTO DELIVERY AFTER THE NEGATIVE RESULT AND THERE WAS NO COMPLICATION. THERE WAS NO SURGICAL PROCEDURES AND PATIENT HAD A VAGINAL DELIVERY. THE CUSTOMER STATED THE PATIENT RECEIVED PROPHYLACTIC TREATMENT (ART) AND WAS ON SOME MEDICATIONS. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2225070 ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 788457 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female