BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 4120701 · Received September 26, 2014

    Report

    Report Number
    1823260-2014-07342
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 4, 2014
    Report Date
    October 14, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. THE CUSTOMER REFUSED FURTHER SUPPORT AND CONSIDERED THE ISSUE RESOLVED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES AFTER PREVENTATIVE MAINTENANCE WAS PERFORMED. DATA WAS ONLY PROVIDED FOR ONE PATIENT SAMPLE. THE INITIAL CHOLESTEROL RESULT WAS "AROUND 15 MMOL/L" AND WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2014, THE LAB RECEIVED A CALL FROM A GENERAL PRACTITIONER (GP) WHO SAID HE DID NOT BELIEVE THE RESULT FOR ONE OF HIS PATIENTS. THE LABORATORY REPEATED THE SAMPLE AND THE RESULT WAS "AROUND 6 MMOL/L". THERE WAS NO ADVERSE EVENT. THE CHOLESTEROL REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT WERE NOT PROVIDED. THE CUSTOMER DECLINED A SERVICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600896 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1