BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15888136 · Received November 30, 2022

    Report

    Report Number
    1221359-2022-10204
    Event Type
    Malfunction
    Date Received
    November 30, 2022
    Date of Event
    November 1, 2022
    Report Date
    February 15, 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 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 OR UPON RECEIPT OF NEW INFORMATION. SINGLE-USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    THE DATE PROVIDED IN B3 IS AN ESTIMATE AS THE EXACT DATE OF OCCURRENCE WAS NOT PROVIDED. FURTHER INFORMATION WAS RECEIVED FROM THE CUSTOMER, IT WAS DETERMINED THAT THOSE RECEIVING A FALSE POSITIVE RESULT WERE EITHER MALE OR A NON-PREGNANT FEMALE PATIENT. AS SUCH, THE RISK OF A SERIOUS ADVERSE EVENT IS LOW AND NOT LIKELY TO CAUSE A DEATH OR SERIOUS INJURY. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4 (EXP DATE), H4. INVESTIGATION CONCLUSION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 193609 WITH POSITIVE QUALITY CONTROL SAMPLES AND INTERNAL NEGATIVE QUALITY CONTROL SAMPLES. 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: 193609, DEVICE PART NUMBER 10732998 / LOT: 174341. 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 193609 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. H3 OTHER TEXT : SINGLE-USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNKNOWN QUANTITY OF FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON OR BEFORE (B)(6) 2022. THIS MFR. REPORT IS TWO (2) OF FOUR (4) AND LOT NUMBER 174341. THE QUANTITY OF FALSE RESULTS PER LOT NUMBER WAS NOT PROVIDED. CONFIRMATION TESTING VIA PCR PERFORMED AT A THIRD-PARTY LAB (PLATFORM: UNKNOWN) GENERATED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNKNOWN QUANTITY OF FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON OR BEFORE (B)(6) 2022. THIS MFR. REPORT IS TWO (2) OF FOUR (4) AND LOT NUMBER 193609. THE QUANTITY OF FALSE RESULTS PER LOT NUMBER WAS NOT PROVIDED. THE CUSTOMER STATED A BLOOD SAMPLE WAS TESTED FROM A FINGERSTICK. CONFIRMATION TESTING VIA PCR PERFORMED AT A THIRD-PARTY LAB (PLATFORM: UNKNOWN) ON AN INTRAVENOUS BLOOD SAMPLE GENERATED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNKNOWN QUANTITY OF FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON OR BEFORE (B)(6) 2022. THIS MFR. REPORT IS TWO (2) OF FOUR (4) AND LOT NUMBER 193609. THE QUANTITY OF FALSE RESULTS PER LOT NUMBER WAS NOT PROVIDED. THE CUSTOMER STATED A BLOOD SAMPLE WAS TESTED FROM A FINGERSTICK. CONFIRMATION TESTING VIA PCR PERFORMED AT A THIRD-PARTY LAB (PLATFORM: UNKNOWN) ON AN INTRAVENOUS BLOOD SAMPLE GENERATED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2526677 ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 193609 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown