BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 4162144 · Received October 10, 2014

    Report

    Report Number
    1823260-2014-07784
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    October 1, 2014
    Report Date
    February 13, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED TO HAVE THE INSTRUMENT DECONTAMINATED. SHE STATED THE FIELD SERVICE REPRESENTATIVE HAS PERFORMED PREVENTIVE MAINTENANCE SINCE THE EVENT, AND THEY HAVE HAD NO FURTHER ISSUES.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS UNABLE TO DETERMINE THE CAUSE OF THE EVENT WITH THE INFORMATION AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER BUT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE MAGNESIUM GEN 2 RESULT FOR ONE PATIENT ON THEIR C501 ANALYZER. THE PATIENT'S INITIAL MAGNESIUM RESULT WAS 3.5 MG/DL AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE TECHNICIAN SAW THAT THE PATIENT'S PREVIOUS MAGNESIUM RESULT WAS LOWER AND REPEATED THE SAMPLE. THE REPEAT RESULT WAS 2.0 MG/DL. A CORRECTED REPORT WAS ISSUED. THE PATIENT WAS NOT TREATED BASED ON THE ORIGINAL RESULT AND THERE WERE NO ADVERSE EVENTS. THE MAGNESIUM REAGENT LOT NUMBER WAS 69923401 AND THE EXPIRATION DATE WAS 02/29/2016. THE FIELD SERVICE REPRESENTATIVE COULD NOT DUPLICATE THE DISCREPANT RESULT NOR DETERMINE THE CAUSE. HE CHECKED AND ADJUSTED THE INTERNAL AND EXTERNAL RINSE WATER. HE CHECKED ALL THE RINSE TUBING FOR LEAKAGES. HE REPLACED THE DETERGENT 1 TUBING, SAMPLE PROBE, AND R1 AND R2 REAGENT PROBES AS PREVENTATIVE MEASURES. HE PERFORMED MECHANICAL CHECKS TO VERIFY THE ANALYZER WAS FUNCTIONING NORMALLY. HE RAN A PRECISION CHECK. THE CUSTOMER PERFORMED CALIBRATION AND QUALITY CONTROL WHICH WERE OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643586 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1