BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I B12 REAGENT KIT

    MDR report key: 17267459 · Received July 6, 2023

    Report

    Report Number
    3005094123-2023-00169
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 19, 2023
    Report Date
    August 31, 2023
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CDD
    PMA / PMN Number
    K121314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I B12 REAGENT KIT, LIST NUMBER 07P67-32, ABBOTT IRELAND DIAGNOSTICS DIVISION, LISNAMUCK, LONGFORD, IRELAND, N39E932 TO ALINITY I PROCESSING MODULE, LIST NUMBER 03R65-01, ABBOTT LABORATORIES, 1915 HURD DRIVE, IRVING, TX, 75038. MDR NUMBER 3016438761-2023-00462 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 B12 REAGENT KIT, LIST NUMBER 07P67-32, TO ALINTY I PROCESSING MODULE, LIST NUMBER 03R65-01. MDR NUMBER 3016438761-2023-00462 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I B12 RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT 115.1 PMOL/L (LOT 47142UD00) REPEATED 241.7 PMOL/L (LOT 50558UD00) AND 145.0 PMOL/L (LOT 50558UD00). THE CUSTOMER BELIEVES THAT 115.1 AND 145.0 PMOL/L ARE THE CORRECT RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I B12 RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT 115.1 PMOL/L (LOT 47142UD00). REPEATED 241.7 PMOL/L (LOT 50558UD00) AND 145.0 PMOL/L (LOT 50558UD00). THE CUSTOMER BELIEVES THAT 115.1 AND 145.0 PMOL/L ARE THE CORRECT RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1788515 ALINITY I B12 REAGENT KIT RADIOASSAY, VITAMIN B12 CDD ABBOTT IRELAND DIAGNOSTICS DIVISION 50558UD00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY I PROCESSING MODU, 03R65-01, AI03386| ALNTY I PROCESSING MODU, 03R65-01, AI03386