BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 19794811 · Received July 22, 2024

    Report

    Report Number
    3005094123-2024-00383
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    April 26, 2024
    Report Date
    September 3, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740121518
    PMA / PMN Number
    K170317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE ALINITY I TOTAL -HCG RESULT INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, AND LABELING REVIEW. ADDITIONALLY, AN IN-HOUSE TESTING OF RETAINED REAGENT KIT WAS ALSO COMPLETED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT IS PERFORMING AS EXPECTED FOR THIS PRODUCT. A REVIEW OF THE COMPLAINT TRENDING REPORT DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LOT NUMBER 60340UD00 AND COMPLAINT ISSUE. AN ACCURACY TESTING WAS COMPLETED WITH A RETAINED KIT OF THE COMPLAINT LOT. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET WHICH DEMONSTRATES THAT THE LOT IS PERFORMING AS EXPECTED. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I TOTAL -HCG REAGENT LOT 60340UD00.

    Additional Manufacturer Narrative · 0

    SECTION A1 - PATIENT IDENTIFIER: COMPLETE SID IS (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ALINITY I TOTAL B-HCG, LIST NUMBER 07P51-30, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21 / 31. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR ONE PATIENT. THE PATIENT WAS RETESTED AND THE RESULT WAS NEGATIVE. THE FOLLOWING DATA WAS PROVIDED (= 5.00 IU/L IS NEGATIVE, >5.00 TO <25.00 IU/L IS GRAYZONE, = 25.00 IU/L IS POSITIVE): (B)(6) 2024 SID (B)(6) RESULT = 2,459.72 IU/L (POSITIVE). (B)(6) 2024 SID (B)(6) RESULT = NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR ONE PATIENT. THE PATIENT WAS RETESTED AND THE RESULT WAS NEGATIVE. THE FOLLOWING DATA WAS PROVIDED (= 5.00 IU/L IS NEGATIVE, >5.00 TO <25.00 IU/L IS GRAYZONE, = 25.00 IU/L IS POSITIVE): ON (B)(6) 2024 SID (B)(6) RESULT = 2,459.72 IU/L (POSITIVE). ON (B)(6) 2024 SID (B)(6) RESULT = NEGATIVE . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2075599 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 60340UD00 00380740121518

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6) | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)