BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 15802023 · Received November 15, 2022

    Report

    Report Number
    3005094123-2022-00255
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    October 26, 2022
    Report Date
    January 17, 2023
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    PMA / PMN Number
    K170317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I TOTAL B-HCG REAGENT KIT, 07P51-20, LONGFORD TO ALINITY I PROCESSING MODULE, 03R65-01, IRVING IA/CC. MDR NUMBER 3016438761-2023-00018-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER. H3 OTHER TEXT : AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I TOTAL B-HCG REAGENT KIT, 07P51-20, LONGFORD TO ALINITY I PROCESSING MODULE, 03R65-01, IRVING IA/CC. MDR NUMBER 3016438761-2023-00018-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P51-20 HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21/-31. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER: (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOTAL ¿-HCG RESULTS FOR 2 PATIENTS. THE FOLLOWING DATA WAS PROVIDED (INTERPRETATION OF RESULTS: </= 5.00 MIU/ML = NEGATIVE, >/= 25.00 MIU/ML = POSITIVE, > 5.00 MIU/ML TO < 25.00 MIU/ML = GRAYZONE):GREATER THAN OR EQUAL TO 25.00 MIU/ML (25.00 IU/L) = POSITIVE): SAMPLE ID (B)(6) INITIAL RESULT = 40; REPEAT RESULT = <2 SAMPLE ID (B)(6) INITIAL RESULT = 25; REPEAT RESULT = 3 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOTAL -HCG RESULTS FOR 2 PATIENTS. THE FOLLOWING DATA WAS PROVIDED (INTERPRETATION OF RESULTS: </= 5.00 MIU/ML = NEGATIVE, >/= 25.00 MIU/ML = POSITIVE, > 5.00 MIU/ML TO < 25.00 MIU/ML = GRAYZONE):GREATER THAN OR EQUAL TO 25.00 MIU/ML (25.00 IU/L) = POSITIVE): (B)(6) INITIAL RESULT = 40; REPEAT RESULT = <2. (B)(6) INITIAL RESULT = 25; REPEAT RESULT = 3. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192446 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA A.I.D.D LONGFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown