BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT B12

    MDR report key: 3511905 · Received December 10, 2013

    Report

    Report Number
    3005094123-2013-00057
    Event Type
    Malfunction
    Date Received
    December 10, 2013
    Report Date
    November 1, 2013
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    CDD
    PMA / PMN Number
    K110579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3008344661-2013-00050. THE INCORRECT MANUFACTURING LOCATION WAS DOCUMENTED. THIS REPORT WAS GENERATED TO DOCUMENT (B)(4) AS THE MANUFACTURE LOCATION. FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. AN ACCURACY TESTING PROTOCOL WAS EXECUTED USING LOT 27905UI00; TESTING MET THE ACCEPTANCE CRITERIA AND DETERMINED THE REAGENT IS PERFORMING ACCEPTABLY. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND FOR THE LOT IN QUESTION. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY AND NO MALFUNCTION OF THE ARCHITECT B12 ASSAY, LIST 07K61, LOT 27905UI00, WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED AN ERRATIC B12 RESULT WHILE USING THE ARCHITECT B12 ASSAY. IT IS UNCLEAR WHICH RESULT IS CORRECT. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS (REFERENCE RANGE 187-883 PG/ML): (B)(6) 2011: 239 PG/ML; (B)(6) 2013: 239 PG/ML; (B)(6) 2013: 147 PG/ML; (B)(6) 2013: 97 PG/ML. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645794 ARCHITECT B12 CDD A.I.D.D LONGFORD 27905UI00

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR LN 03M74-02, SN (B)(4)| ARCHITECT I2000SR ANALYZER