BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16557593 · Received March 16, 2023

    Report

    Report Number
    1221359-2023-00512
    Event Type
    Malfunction
    Date Received
    March 16, 2023
    Date of Event
    February 24, 2023
    Report Date
    May 11, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION. SINGLE-USE, DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 195988 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 195988 A, TEST BASE PART NUMBER 1073298/ LOT 181324. 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 195988 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 IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLES. H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULT WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO PERFORMED ON (B)(6) 2023 ON A SERUM SAMPLE. CONFIRMATION TESTING WAS PERFORMED TWICE (BIOROD GENIUS AND ARCHITECT ANTIBODY ANTIGEN) AND GENERATED NEGATIVE RESULTS. REPEAT TESTING WAS PERFORMED AND GENERATED POSITIVE RESULT. THE CUSTOMER STATED THAT PATIENT WAS PREGNANT AT THE TIME OF THE TEST. 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 FALSE POSITIVE RESULT WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO PERFORMED ON (B)(6) 2023 ON A SERUM SAMPLE. CONFIRMATION TESTING WAS PERFORMED TWICE (BIOROD GENIUS AND ARCHITECT ANTIBODY ANTIGEN) AND GENERATED NEGATIVE RESULTS. REPEAT TESTING WAS PERFORMED AND GENERATED POSITIVE RESULT. THE CUSTOMER STATED THAT PATIENT WAS PREGNANT AT THE TIME OF THE TEST. 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
    843633 ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 195988 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female