BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS VITAMIN B12 COBALAMIN

    MDR report key: 16644196 · Received March 30, 2023

    Report

    Report Number
    9680746-2023-00004
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    March 23, 2023
    Report Date
    March 30, 2023
    Manufacturer
    CLARE DISCRETE MFG IO
    Product Code
    CDD
    UDI-DI
    15099590224301
    PMA / PMN Number
    K140496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FULL PATIENT IDENTIFIER IS (B)(6). CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. THE ACCESS VITAMIN B12 REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK AND CALIBRATION WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. AS CUSTOMER DID NOT PERFORM QC TESTING, QC TRENDS WERE NOT PROVIDED FOR REVIEW. IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    ON 26MAR2023 THE CUSTOMER REPORTED OBTAINING ERRONEOUS LOW B12 (ACCESS B12, PART NUMBER 33000 AND LOT NUMBER 272194) RESULT OF 0 PG/ML WAS OBTAINED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE CUSTOMER REPEATED THE PATIENT SAMPLE AND OBTAINED THE SAME VALUE OF 0 PG/ML. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THE PATIENT WAS ADMINISTERED A VITAMIN B12 SHOT (DOSE NOT PROVIDED). THE PATIENT WAS REDRAWN AND RETESTED FOR B12 THE FOLLOWING DAY AND A RESULT OF >1504 PG/ML (OVER RANGE FLAGGED) WAS OBTAINED. THERE IS NO FURTHER REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT OR PATIENT INJURY. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK AND CALIBRATION WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THE CUSTOMER DOES NOT PERFORM QUALITY CONTROL (QC) TESTING; THEREFORE, THERE ARE NO QC RESULTS FOR REVIEW. SAMPLE COLLECTION AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, VOLUME COLLECTED, CENTRIFUGATION TIME AND SPEED AND OTHER SAMPLE HANDLING INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592263 ACCESS VITAMIN B12 COBALAMIN RADIOASSAY, VITAMIN B12 CDD CLARE DISCRETE MFG IO 33000 272194 15099590224301

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other