BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA CALCIUM

    MDR report key: 1873345 · Received October 19, 2010

    Report

    Report Number
    1823260-2010-06184
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 28, 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
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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

    CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE MULTICLIX DEVICE. NO ACCIDENTAL NEEDLE STICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    THE FIELD APPLICATION SPECIALIST REPORTED THE USER EXPERIENCED ISSUES WITH CALCIUM QUALITY CONTROL AND PATIENT RESULTS FROM THE COBAS 6000 ANALYZER SERIAL NUMBER (B)(4). OF THE PATIENT DATA PROVIDED, THE RESULTS FOR SIX PATIENT SAMPLES WERE DISCREPANT. ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 8.2 AND THE REPEAT RESULT WAS 9.0. PATIENT SAMPLE 2 INITIAL RESULT WAS 8.4 AND THE REPEAT RESULT WAS 9.3. PATIENT SAMPLE 3 INITIAL RESULT WAS 8.3 AND THE REPEAT RESULT WAS 9.1. PATIENT SAMPLE 4 INITIAL RESULT WAS 8.9 AND THE REPEAT RESULT WAS 9.7. PATIENT SAMPLE 5 INITIAL RESULT WAS 8.2 AND THE REPEAT RESULT WAS 9.1. PATIENT SAMPLE 6 INITIAL RESULT WAS 8.4 AND THE REPEAT RESULT WAS 9.4. NONE OF THE PATIENTS WERE ADVERSELY AFFECTED AS NONE OF THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE USER REPEATED SAMPLES OF PREVIOUSLY TESTED SURVEY MATERIAL. OF THE DATA PROVIDED, THE RESULTS FOR FOUR SAMPLES WERE DISCREPANT. SURVEY SAMPLE 1 INITIAL RESULT WAS 9.5 AND THE REPEAT RESULT WAS 10.5. SURVEY SAMPLE 2 INITIAL RESULT WAS 9.0 AND THE REPEAT RESULT WAS 9.8. SURVEY SAMPLE 3 INITIAL RESULT WAS 10.4 AND THE REPEAT RESULT WAS 11.2. SURVEY SAMPLE 4 INITIAL RESULT WAS 12.2 AND THE REPEAT RESULT WAS 13.4. THE FIELD APPLICATION SPECIALIST DETERMINED THERE WAS A POSSIBLE REAGENT LOT ISSUE.

    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