BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA CALCIUM

    MDR report key: 1841354 · Received September 22, 2010

    Report

    Report Number
    1823260-2010-05618
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 8, 2010
    Report Date
    October 21, 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

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

    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 CUSTOMER ALLEGED QUESTIONABLE RESULTS FOR 10 PATIENT SAMPLES WHEN TESTED FOR CALCIUM ON THE COBAS INTEGRA 400 PLUS ANALYZER. OF THESE 10 SAMPLES, RESULTS FOR 7 WERE PROVIDED AND FOUND TO BE DISCREPANT. INITIAL CALCIUM RESULTS WERE RELEASED OUTSIDE THE LABORATORY AND SOME WERE QUESTIONED BY THE PHYSICIAN. REPEAT TESTING WAS PERFORMED BY A REFERENCE LABORATORY ON A BECKMAN COULTER AV 5400 ANALYZER. REPEAT TESTS WERE PERFORMED EITHER WITH THE SAME SAMPLE OR WITH ANOTHER SAMPLE DRAWN AT THE SAME TIME. CORRECTED REPORTS WERE ISSUED WITH THE REPEAT RESULTS. FOR PATIENT SAMPLE 1, THE INITIAL CALCIUM RESULT WAS 10.5 MG/DL. THE REPEAT CALCIUM RESULT WAS 9.6 MG/DL. PATIENT SAMPLE 2 WAS FROM A MALE, (B)(6). THE INITIAL CALCIUM RESULT WAS 10.9 MG/DL. THE REPEAT CALCIUM RESULT WAS 9.9 MG/DL. PATIENT SAMPLE 3 WAS FROM A MALE, (B)(6). THE INITIAL CALCIUM RESULT WAS 9.7 MG/DL. THE REPEAT CALCIUM RESULT WAS 8.9 MG/DL. PATIENT SAMPLE 4 WAS FROM A FEMALE, (B)(6). THE INITIAL CALCIUM RESULT WAS 9.9 MG/DL. THE REPEAT CALCIUM RESULT WAS 8.9 MG/DL. PATIENT SAMPLE 5 WAS FROM A MALE, (B)(6). THE INITIAL CALCIUM RESULT WAS 10.7 MG/DL. THE REPEAT CALCIUM RESULT WAS 9.6 MG/DL. PATIENT SAMPLE 6 WAS FROM A FEMALE, (B)(6). THE INITIAL CALCIUM RESULT WAS 11.1 MG/DL. THE REPEAT CALCIUM RESULT WAS 10.2 MG/DL. PATIENT SAMPLE 7 WAS FROM A FEMALE, (B)(6). THE INITIAL CALCIUM RESULT WAS 11.8 MG/DL. THE REPEAT CALCIUM RESULT WAS 10.8 MG/DL. THE CUSTOMER STATED THAT PATIENTS WERE UNAFFECTED BY THE ERRONEOUS RESULTS AND THAT HEALTH CARE PROVIDERS DID NOT TREAT THE PATIENTS BASED ON THOSE RESULTS. THE CALCIUM REAGENT LOT NUMBER WAS 62601901. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE FOR THE ISSUE. THE INSTRUMENT WAS CHECKED AND PERFORMANCE TESTS WERE RUN, WHICH WERE WITHIN THE MANUFACTURER'S SPECIFICATIONS. THE CUSTOMER REPLACED THE REAGENT PACK, FOLLOWED BY CALIBRATION AND QUALITY CONTROLS, WHICH PASSED.

    Description of Event or Problem · 1

    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
    1 049 YR