BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM GEN. 2

    MDR report key: 3901566 · Received June 30, 2014

    Report

    Report Number
    1823260-2014-04740
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 19, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHW
    PMA / PMN Number
    K113521
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. AS THE REAGENT PACK WAS DISCARDED, NO FURTHER ROOT CAUSE ANALYSIS WAS POSSIBLE. THE ISSUE DID NOT REOCCUR AFTER USING A NEW REAGENT CASSETTE AND THE ISSUE APPEARS TO HAVE BEEN RESOLVED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER HAD LOADED A NEW CALCIUM GEN.2 REAGENT PACK OF THE SAME LOT ALREADY IN USE ONTO THE COBAS C501 ANALYZER SERIAL NUMBER (B)(4). THE CUSTOMER DID NOT PERFORM QC ON THE REAGENT PACK AND BEGAN TESTING PATIENT SAMPLES. THE CUSTOMER RECEIVED QUESTIONABLE HIGH RESULTS FOR 14 OF THE PATIENT SAMPLES. THE REAGENT PACK IN QUESTION WAS DISCARDED AND A NEW REAGENT PACK OF THE SAME LOT WAS LOADED ONTO THE ANALYZER AND CALIBRATION AND QC WERE PERFORMED WHICH WERE ACCEPTABLE. THE PATIENT SAMPLES WERE THEN RETESTED. DATA WAS ONLY PROVIDED FOR ONE PATIENT SAMPLE THAT HAD TO BE CORRECTED. THE INITIAL RESULT WAS 14.0 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS 9.4 MG/DL AND WAS BELIEVED TO BE CORRECT. THERE WAS NO ADVERSE EVENT. THE CUSTOMER FOUND TWO DISCARDED REAGENT PACKS IN THE GARBAGE AND NOTED ONE HAD A YELLOW SUBSTANCE AROUND THE TOP. THE CUSTOMER WAS NOT CERTAIN THIS WAS THE REAGENT PACK WHICH GENERATED THE QUESTIONABLE RESULTS. THE FIELD SERVICE REPRESENTATIVE STATED THE CALCIUM REAGENT PACK APPEARED TO BE DEFECTIVE. HE HAD THE CUSTOMER REPLACE THE REAGENT RACK AND RUN QC. THE CUSTOMER RAN PRECISION TESTING AND FELT EVERYTHING WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379589 CALCIUM GEN. 2 TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM CHW ROCHE DIAGNOSTICS NA 69747201

    Patients

    Seq Age Sex Outcome Treatment
    1