BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA CALCIUM

    MDR report key: 1871454 · Received October 15, 2010

    Report

    Report Number
    1823260-2010-06167
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 25, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIC
    PMA / PMN Number
    K963292
    Removal / Correction Number
    1823260-09/27/10-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL INVESTIGATIONS REVEALED THE PRESENCE OF PRECIPITATE IN REAGENT 2 (R2) OF THE CALCIUM REAGENT LOT. THE ROOT CAUSE FOR THE PRECIPITATION IS STILL UNDER INVESTIGATION. AN URGENT MEDICAL DEVICE REMOVAL NOTICE WAS MAILED OCTOBER 13, 2010 TO ALL CUSTOMERS TO IMMEDIATELY DISCONTINUE USE OF THE CALCIUM REAGENT LOT. CALCIUM DEVIATIONS OF > 20% ABOVE AND BELOW THE REFERENCE RANGE ARE CONSIDERED CRITICAL. THESE DEVIATIONS COULD LEAD TO NON-DETECTION OF A PATHOLOGICAL STATUS OR MAY LEAD TO UNNECESSARY THERAPEUTIC CONSEQUENCES. THE ERRONEOUS BIAS CAUSED BY THIS ASSAY LOT MAY CAUSE PATIENT SAMPLES WITH CRITICALLY HIGH OR CRITICALLY LOW CALCIUM LEVELS TO HAVE RESULTS THAT APPEAR TO BE IN THE NORMAL RANGE. THESE PATIENTS MAY BE AT HIGH RISK FOR MISDIAGNOSIS OF PATHOLOGICAL CONDITIONS ASSOCIATED WITH ABNORMAL CALCIUM LEVELS. INACCURATELY HIGH CALCIUM VALUES MAY LEAD TO AN INCORRECT DIAGNOSIS DEPENDING ON THE BLOOD CALCIUM LEVEL. IN THE WORST CASE, THE WRONG THERAPY MAY BE INITIATED. SUSPECTED HYPERCALCEMIA WOULD MEAN CONFIRMING THE CALCIUM VALUE QUICKLY, AND TREATMENT WOULD OCCUR ACCORDING TO THE CLINICAL PICTURE. A PATIENT NORMALLY SHOWS OBVIOUS SYMPTOMS IF THE CALCIUM VALUE IS >12 MG/DL. IN THE CASE OF INACCURATELY LOW VALUES, THE CALCIUM VALUE MUST BE INTERPRETED TOGETHER WITH OTHER PARAMETERS (E.G., MAGNESIUM, PHOSPHATE, AND PTH). UNNECESSARY FURTHER EXAMINATION AND BLOOD COLLECTION MAY RESULT.

    Description of Event or Problem · 1

    (B)(6) HEALTHCARE CONTACTED (B)(4) SALES CONSULTANT ON (B)(6)-2010. A STAFF MEMBER WAS EXPOSED TO RAPICIDE PA, IT SPLASHED IN HER EYE WHILE HELPING ANOTHER PERSON CHANGE THE CHEMICAL.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE HIGH RESULT FOR CALCIUM ON THE COBAS C501 ANALYZER. THE EVENT INVOLVED ONE PATIENT SAMPLE COLLECTED FROM A PATIENT IN THE EMERGENCY ROOM, WHICH GAVE DISCREPANT RESULTS FOR CALCIUM. THE INITIAL RESULT FOR CALCIUM GAVE 12.22 MG/DL. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY. THE ER PHYSICIANS QUESTIONED THIS RESULT AND REQUESTED THE PATIENT BE REDRAWN. THE REDRAWN SAMPLE WAS RUN ON THIS C501 ANALYZER GIVING A CALCIUM RESULT OF 9.45 MG/DL THE USER RERAN THE ORIGINAL SAMPLE TWICE GIVING CALCIUM RESULTS OF 9.43 MG/DL WHEN RUN ON THIS C501 ANALYZER AND 9.4 MG/DL WHEN RUN ON THE INTEGRA 400 ANALYZER. NO ADVERSE EVENTS WERE ALLEGED REGARDING THIS DISCREPANCY. THE CALCIUM REAGENT LOT NUMBER WAS 62601901. THE FIELD SERVICE REPRESENTATIVE FOUND A FLUIDICS PROBLEM WITH THE CELL RINSE MECHANISM. HE REPLACED TUBING, A VALVE AND ADJUSTED THE RINSE. PERFORMANCE TESTS WERE RUN AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA CALCIUM CRESOLPHTHALEIN COMPLEXONE, CALCIUM CIC ROCHE DIAGNOSTICS 62601901

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR