BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA CALCIUM

    MDR report key: 1871973 · Received October 18, 2010

    Report

    Report Number
    1823260-2010-06171
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIC
    PMA / PMN Number
    K951595
    Removal / Correction Number
    1823260-09/27/10-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    THE USER RECEIVED QUESTIONABLE CALCIUM RESULTS FOR QUALITY CONTROL AND PATIENT SAMPLES AND PROVIDED DATA FOR 11 PATIENT SAMPLES. ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 10.3 AND THE REPEAT RESULT WAS 8.5. THE REPEAT RESULT OF 9.2 FROM THE COBAS 6000 ANALYZER WAS REPORTED AS THE CORRECTED RESULT. PATIENT SAMPLE 2 INITIAL RESULT WAS 9.3 AND THE REPEAT RESULT WAS 7.2. THE REPEAT RESULT OF 7.8 FROM THE COBAS 6000 ANALYZER WAS REPORTED AS THE CORRECTED RESULT. PATIENT SAMPLE 3 INITIAL RESULT WAS 10.5 AND THE REPEAT RESULT FROM THE COBAS 6000 ANALYZER OF 8.2 WAS REPORTED AS THE CORRECTED RESULT. PATIENT SAMPLE 4 INITIAL RESULT WAS 9.4 AND THE REPEAT RESULT FROM THE COBAS 6000 ANALYZER OF 8.6 WAS REPORTED AS THE CORRECTED RESULT. PATIENT SAMPLE 5 INITIAL RESULT WAS 10.6 AND THE REPEAT RESULT FROM THE COBAS 6000 ANALYZER OF 9.0 WAS REPORTED AS THE CORRECTED RESULT. PATIENT SAMPLE 6 INITIAL RESULT WAS 11.0 AND THE REPEAT RESULT FROM THE COBAS 6000 ANALYZER OF 9.2 WAS REPORTED AS THE CORRECTED RESULT. PATIENT SAMPLE 7 INITIAL RESULT WAS 10.4 AND THE REPEAT RESULT FROM THE COBAS 6000 ANALYZER OF 9.2 WAS REPORTED AS THE CORRECTED RESULT. PATIENT SAMPLE 8 INITIAL RESULT WAS 9.4 AND THE REPEAT RESULT FROM THE COBAS 6000 ANALYZER OF 7.3 WAS REPORTED AS THE CORRECTED RESULT. PATIENT SAMPLE 9 INITIAL RESULT WAS 12.2 AND THE REPEAT RESULT FROM THE COBAS 6000 ANALYZER OF 10.7 WAS REPORTED AS THE CORRECTED RESULT. PATIENT SAMPLE 10 INITIAL RESULT WAS 11.3 AND THE REPEAT RESULT OF 9.9 WAS REPORTED AS THE CORRECTED RESULT. PATIENT SAMPLE 11 INITIAL RESULT WAS 10.0 AND THE REPEAT RESULT OF 8.7 WAS REPORTED AS THE CORRECTED RESULT. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE USER DID NOT KNOW IF THE PATIENTS WERE ADVERSELY AFFECTED AND WAS NOT ABLE TO FIND OUT MORE INFORMATION. THE CALCIUM REAGENT LOT NUMBER WAS 62601901. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS CONTAMINATION AND CLEANED THE WATER SYSTEM AND REPLACED PARTS. TO VERIFY THE ANALYZER OPERATION, THE USER RAN PATIENT SAMPLES AND QUALITY CONTROL FOR CALCIUM WHICH WERE WITHIN SPECIFICATIONS. THE FIELD SERVICE REPRESENTATIVE RAN PRECISION TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WERE EXHIBITING HIGH OUT OF RANGE SHOCKING LEAD IMPEDANCES GREATER THAN 125 OHMS. THE IMPEDANCES HAD BEEN TRENDING UPWARD IN THE LAST TWO MONTHS. WITHIN THE LAST TWO WEEKS, THERE HAD BEEN SEVERAL INSTANCES OF GREATER THAN 125 OHM IMPEDANCES WITH SOME FLUCTUATIONS. THE PATIENT WAS CURRENTLY WEARING A BACK BRACE. A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT RECOMMENDED OBTAINING A CHEST X-RAY. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1