BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3783838 · Received May 1, 2014

    Report

    Report Number
    1823260-2014-03125
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZV
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. RESULTS - DEVICE SUBASSEMBLY- ISE SAMPLING ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ION SELECTIVE ELECTRODE (ISE) POTASSIUM (K) ON "A FEW" SAMPLES. IT WAS DETERMINED THAT ONE SAMPLE HAD AN ERRONEOUS RESULT WHICH WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER INDICATED THEY HAD BEEN RECEIVING ISE REAGENT PROBE ALARMS. THE CUSTOMER INDICATED THE PROBE DID NOT APPEAR BENT OR DAMAGED, BUT THAT THE PROBE WAS STUCK ON THE SIDE OF ONE OF THE REAGENT BOTTLES. THE INITIAL K RESULT WAS 5.3 MMOL/L, WHICH WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501 INSTRUMENT AND GENERATED A RESULT OF 3.2 MMOL/L. THE CUSTOMER DEEMED THE REPEAT RESULT TO BE CORRECT AND CORRECTED THE RESULT. THERE WAS NO ADVERSE EVENT. THE LOT NUMBER AND EXPIRATION DATE OF THE K ELECTRODE IN USE WAS REQUESTED, BUT THE CUSTOMER COULD NOT PROVIDE THIS INFORMATION. THE FIELD SERVICE REPRESENTATIVE FOUND THAT THE SAMPLING ASSEMBLY ISE PROBE WAS MISADJUSTED. HE ADJUSTED THE SAMPLING ASSEMBLY ISE PROBE AND PERFORMED MECHANICAL CHECKS, WHICH PASSED. HE ALSO PERFORMED PRECISION TESTING, WHICH PASSED. THE CUSTOMER INDICATED THAT QC MET LABORATORY SPECIFICATIONS. THE INVESTIGATION DETERMINED THE MIS-ADJUSTED SAMPLING ASSEMBLY ISE PROBE DID NOT EXPLAIN THE FACT THAT ONLY ERRONEOUS K RESULTS WERE GENERATED. THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE WITH THE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263691 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER MZV ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR