BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA CALCIUM

    MDR report key: 1871746 · Received October 15, 2010

    Report

    Report Number
    1823260-2010-06169
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 24, 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
    SC, 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

    BOSTON SCIENTIFIC CRM RECEIVED INITIAL INFORMATION THAT THIS PATIENT HAS A CHRONIC ISSUE WITH THIS RIGHT ATRIAL (RA) LEAD. HISTORICAL OBSERVATIONS OVER THE PAST YEAR INVOLVED REPRODUCIBLE NOISE AND VARIABLE LEAD IMPEDANCE VALUES. HOWEVER, THESE OBSERVATIONS DID NOT IMPACT THERAPY DELIVERY. APPROXIMATELY ONE YEAR LATER, THE SYSTEM WAS REPROGRAMMED TO ENCOURAGE BETTER PACING SYNCHRONY FOR THE PATIENT, AND THE PATIENT RETURNED HOME. NEW INFORMATION WAS RECEIVED FOUR MONTHS LATER FROM THE PATIENT THAT DURING A ROUTINE FOLLOW-UP VISIT, THE NURSE SUSPECTED HIS LEAD WAS CRACKED. AS THERE WAS A PHYSICAL PROBLEM WITH THE LEAD, THIS WAS CAUSING EXCESSIVE NOISE. THERE WAS NO RESOLUTION COMMUNICATED TO THE PATIENT ON HOW THE ISSUE WOULD BE RESOLVED. NO ADVERSE EFFECTS WERE REPORTED.

    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 PROVIDED DATA FOR FIVE PATIENT SAMPLES WHICH WERE DISCREPANT. THE REPEAT TESTING WAS PERFORMED ON INTEGRA 800 SERIAL NUMBER (B)(4). ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 10.67 AND THE REPEAT RESULT WAS 9.1. PATIENT SAMPLE 2 WAS FROM A (B)(6) MALE PATIENT. THE INITIAL RESULT WAS 10.42 AND THE REPEAT RESULT WAS 8.6. PATIENT SAMPLE 3 WAS FROM A (B)(6) MALE PATIENT. THE INITIAL RESULT WAS 10.20 AND THE REPEAT RESULT WAS 9.1. PATIENT SAMPLE 4 WAS FROM A (B)(6) FEMALE PATIENT. THE INITIAL RESULT WAS 11.0 AND THE REPEAT RESULT WAS 9.7. PATIENT SAMPLE 5 WAS FROM A (B)(6) FEMALE PATIENT. THE INITIAL RESULT WAS 10.06 AND THE REPEAT RESULT WAS 9.1. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE REAGENT WAS THE CAUSE. THE USER LOADED A NEW REAGENT CASSETTE AND HE PERFORMED INSTRUMENT CHECKS WITH ACCEPTABLE RESULTS. TO VERIFY THE ANALYZER OPERATION, THE USER RAN CALIBRATION AND QUALITY CONTROL.

    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
    1 053 YR