BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA CALCIUM

    MDR report key: 1871453 · Received October 15, 2010

    Report

    Report Number
    1823260-2010-06165
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ROCHE DIAGNOSTICS CORPORATION
    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
    NY, 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

    THE USER RECEIVED QUESTIONABLE CALCIUM RESULTS FOR PATIENT SAMPLES FROM THE INTEGRA 800 SERIAL NUMBER (B)(4). THE USER REPLACED THE REAGENT CASSETTE, PERFORMED CALIBRATION AND QUALITY CONTROL AND REPEATED THE PATIENT SAMPLES. OF THE DATA PROVIDED, THE RESULTS FOR TWO PATIENT SAMPLES WERE DISCREPANT. ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 12.1 AND THE REPEAT RESULT WAS 11.0. PATIENT SAMPLE 2 WAS FROM A FEMALE BORN ON (B)(6). THE INITIAL RESULT WAS 12.1 AND THE REPEAT RESULT WAS 10.5. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND CORRECTED. NO TREATMENT WAS GIVEN TO THE PATIENTS DUE TO THE ERRONEOUS RESULTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE REAGENT AND VERIFIED THE USER PUT ON FRESH CALCIUM REAGENT. TO VERIFY THE ANALYZER OPERATION, HE RAN PRECISION TESTING WITH ACCEPTABLE RESULTS AND THE USER RAN CALIBRATION AND QUALITY WITH ACCEPTABLE RESULTS.

    Description of Event or Problem · 1

    CONSUMER STATED THE TIP OF THE TAMPON BROKE OFF WHEN SHE REMOVED IT FROM HER BODY. SHE ATTEMPTED TO REMOVE THE REMAINING PIECE AND THE PIECE CAME OUT IN CLUMPS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 042 YR