BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1638100 · Received March 24, 2010

    Report

    Report Number
    1823260-2010-01783
    Event Type
    Malfunction
    Date Received
    March 24, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 24, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Description of Event or Problem · 1

    USER EXPERIENCED ISSUE WITH LOW CONTROL RECOVERY FOR CKMB WHEN SWITCHING TO A NEW LOT OF CKMB REAGENT. USER PULLED TWO PATIENT SAMPLES THAT HAD BEEN PREVIOUSLY TESTED FOR CKMB USING THE OLD LOT OF REAGENT AND RERAN THESE SAMPLES ON (B)(6) 2010, USING THE NEW LOT OF REAGENT FOR COMPARISON. THE OLD LOT IS 153686. THE NEW LOT IS 155150. THE FOLLOWING DISCREPANT PATIENT RESULTS WERE RECEIVED: SAMPLE 1, ORIGINAL RESULT FROM (B)(6) 2010, USING OLD LOT GAVE 2.84; NEW LOT GAVE 1.94 NG PER ML. SAMPLE 2, ORIGINAL RESULT FROM (B)(6) 2010, USING OLD LOT GAVE 5.01; NEW LOT GAVE 3.51 PER ML. USER SAID THAT THE ORIGINAL CKMB RESULTS FOR BOTH PATIENT SAMPLES WERE REPORTED AND NEITHER HAD BEEN CORRECTED. USER DID NOT CONSIDER ORIGINAL RESULTS ERRONEOUS, BUT DID CONSIDER THE REPEAT RESULTS TO BE ERRONEOUS. THE REPEAT RESULTS WERE NOT REPORTED AND THERE WAS NO AFFECT TO EITHER PATIENT. A REAGENT BULLETIN, WHICH INCLUDES THE NEW LOT USED BY THE CUSTOMER, HAS BEEN ISSUED COMMUNICATING THE CKMB REAGENT HAS BEEN RESTANDARDIZED. CUSTOMER ESTABLISHED NEW CONTROL RANGES FOR THEIR OWN INTERNAL CONTROLS WHILE RUNNING ROCHE CONTROLS WHICH RECOVERED WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1