BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I B12 REAGENT KIT

    MDR report key: 15138013 · Received August 1, 2022

    Report

    Report Number
    3005094123-2022-00159
    Event Type
    Malfunction
    Date Received
    August 1, 2022
    Date of Event
    July 21, 2022
    Report Date
    September 27, 2022
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    CDD
    PMA / PMN Number
    K121314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCHES DETERMINED NORMAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT FOR THE ISSUE OBSERVED. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 38197UD00, WHICH DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. TESTING MEETS ACCEPTANCE CRITERIA, AND THE PRODUCT IS PERFORMING AS EXPECTED. LABELLING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. AS PER PRODUCT LABELLING, RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER DATA; E.G., SYMPTOMS, RESULTS OF OTHER TESTS, AND CLINICAL IMPRESSIONS. BASED ON ALL REVIEWED DATA, WE CONCLUDE THAT THERE IS NO PRODUCT DEFICIENCY WITH THE ALINITY I B12 REAGENT IDENTIFIED IN THIS COMPLAINT. THIS FOLLOW UP INCLUDES A CORRECTION TO INCLUDE THE CODES IN SECTION H6 FOR COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS THAT WERE NOT INCLUDED IN THE INITIAL REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I B12 RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT (B)(6) 2022) 117 PG/ML, REPEATED (B)(6) 2022) 103 PG/ML, PRECISION MEASUREMENT 128, 158, 110, 132, 114, 110, 92, 99, 106, 111 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2924879 ALINITY I B12 REAGENT KIT RADIOASSAY, VITAMIN B12 CDD A.I.D.D LONGFORD 38197UD00

    Patients

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