BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3250063 · Received July 26, 2013

    Report

    Report Number
    1823260-2013-04503
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    June 30, 2013
    Report Date
    October 3, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED. FURTHER INVESTIGATION WAS NOT POSSIBLE DUE TO THE LACK OF INFORMATION PROVIDED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER. THE FIELD SERVICE REPRESENTATIVE WENT ON SITE. HE CHECKED THE GEAR PUMP PRESSURE, READJUSTED THE SAMPLES PROBE AND R2 PROBE, AND CHECKED THE LAUNDRY WATER LEVEL. A SYSTEM CHECK TEST WAS OK.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT ON THEIR C501 ANALYZER. THE CUSTOMER WAS QUESTIONING ION SELECTIVE POTASSIUM AND SODIUM, BUN/UREA, CREATININE, ALBUMIN, ALKALINE PHOSPHATASE, TOTAL BILIRUBIN, AND TOTAL PROTEIN RESULTS. OF THOSE, THE POTASSIUM AND CREATININE RESULTS WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE SPECIFIC DATE OF THIS EVENT WAS REQUESTED FROM THE CUSTOMER BUT NOT PROVIDED. THE PATIENT'S INITIAL POTASSIUM RESULT WAS 6.86 MMOL/L. THE PATIENT'S INITIAL CREATININE RESULT WAS 642 UMOL/L. THE PATIENT WAS CALLED INTO THE AMBULANCE AND EMERGENCY AND HAD ANOTHER SAMPLE DRAWN. THE POTASSIUM RESULT WAS 4.86 AND THE CREATININE RESULT WAS 63 UMOL/L. THESE RESULTS CORRELATED TO THE PATIENT'S PREVIOUS RESULTS FROM (B)(6) 2013. THE PATIENT'S ORIGINAL SAMPLE WAS THEN REPEATED. THE FIRST REPEAT POTASSIUM RESULT WAS 7 MMOL/L. THE SECOND REPEAT POTASSIUM RESULT WAS 5.16 MMOL/L. THE REPEAT CREATININE RESULT WAS 247 UMOL/L. THE CUSTOMER STATED THE ORIGINAL SAMPLE WAS TESTED AGAIN AND THE CREATININE RESULT COULD NOT BE REPRODUCED. THE CUSTOMER WAS ASKED IF THE PATIENT WAS ADVERSELY AFFECTED, BUT DID NOT RESPOND. THE CUSTOMER WAS ASKED FOR THE POTASSIUM AND CREATININE REAGENT LOT NUMBERS AND EXPIRATION DATES, BUT DID NOT PROVIDE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351223 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 059 YR