BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DETERMINE HIV 1/2 AG/AB COMBO 25T

    MDR report key: 16380630 · Received February 15, 2023

    Report

    Report Number
    1221359-2023-00316
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    January 31, 2023
    Report Date
    April 28, 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
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER 199525, EXP. DATE 24FEB2024, MFR. DATE 15APR2022; LOT NUMBER 197235, EXP. DATE 22FEB2024, MFR. DATE 02APR2022. THE DATE PROVIDED IS AN ESTIMATE AS THE EXACT DATE OF OCCURRENCE WAS NOT PROVIDED. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. SINGLE USE, DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBER 199525, EXP. DATE 24FEB2024, MFR. DATE 15APR2022; LOT NUMBER 197235, EXP. DATE 22FEB2024, MFR. DATE 02APR2022. THE DATE PROVIDED IN B3 IS AN ESTIMATE AS THE EXACT DATE OF OCCURRENCE WAS NOT PROVIDED. INVESTIGATION FOR LOT 199525: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 199525 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: 199525, TEST BASE PART NUMBER 10732998/ LOT: 191388. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 199525 SHOWED THAT THE COMPLAINT RATE IS (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 SAMPLES. INVESTIGATION FOR LOT 197235: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 197235 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: 197235, TEST BASE PART NUMBER 10732998/ LOT: 191385. 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 197235 SHOWED THAT THE COMPLAINT RATE IS (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 SAMPLES. H3 OTHER TEXT : SINGLE USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T FOR THREE (3) TESTS USING TWO LOTS PERFORMED ON OR BEFORE (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF THREE (3). THE CUSTOMER WAS UNABLE TO DETERMINE WHICH PATIENTS WERE TESTED WITH WHICH LOTS. ALTHOUGH REQUESTED, NO INFORMATION REGARDING REPEATED AND CONFIRMATION TESTING WAS PROVIDED. NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T FOR THREE (3) TESTS USING TWO LOTS PERFORMED ON OR BEFORE (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF THREE (3). THE CUSTOMER WAS UNABLE TO DETERMINE WHICH PATIENTS WERE TESTED WITH WHICH LOTS. ALTHOUGH REQUESTED, NO INFORMATION REGARDING REPEATED AND CONFIRMATION TESTING WAS PROVIDED. NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140669 DETERMINE HIV 1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. UNKNOWN 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown