BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA CALCIUM

    MDR report key: 1886279 · Received October 29, 2010

    Report

    Report Number
    1823260-2010-06466
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 29, 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
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICATIONS FOR PATIENT 1 ARE INCLUDED IN THE ATTACHMENT TO THE MEDWATCH. PATIENT 3 MEDICATION WAS CITALOPRAM. PATIENT 4 MEDICATIONS WERE TOPEROL, AVALIDE. PATIENT 5 MEDICATION WAS TRAZIDONE. PATIENT 6 MEDICATIONS WERE ADVAIR, ALBUTEROL, CINGULAR, PRANSIN. PATIENT 8 MEDICATIONS WERE DIAVAN, PREDNISONE, PRILOSEC, LEXIPRO, SYNTHROID.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE CALCIUM RESULTS FROM THE INTEGRA 400 SERIAL NUMBER (B)(4). THE USER LOADED A NEW REAGENT CASSETTE OF THE SAME LOT NUMBER AND REPEATED TESTING OF THE SAMPLES. DATA FOR EIGHT PATIENT SAMPLES WAS PROVIDED. ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 11.0, REPEAT RESULT WAS 9.1. PATIENT SAMPLE 2 FROM A FEMALE BORN ON (B)(6), INITIAL RESULT WAS 10.9, REPEAT RESULT WAS 9.2. PATIENT SAMPLE 3 FROM A FEMALE BORN ON (B)(6), INITIAL RESULT WAS 12.1, REPEAT RESULT WAS 10.0. PATIENT SAMPLE 4 FROM A FEMALE BORN ON (B)(6), INITIAL RESULT WAS 11.6, REPEAT RESULT WAS 9.5. PATIENT SAMPLE 5 FROM A FEMALE BORN ON (B)(6), INITIAL RESULT WAS 12.4, REPEAT RESULT WAS 9.5. PATIENT SAMPLE 6 FROM A FEMALE BORN ON (B)(6), INITIAL RESULT WAS 11.6, REPEAT RESULT WAS 9.6. PATIENT SAMPLE 7 FROM A MALE BORN ON (B)(6), INITIAL RESULT WAS 12.0, REPEAT RESULT WAS 9.5. PATIENT SAMPLE 8 FROM A FEMALE BORN ON (B)(6), INITIAL RESULT WAS 10.9, REPEAT RESULT WAS 9.3. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT TREATED BASED ON THE ERRONEOUS RESULTS. THE USER DECLINED A SERVICE VISIT AS THE ISSUE WAS RESOLVED BY LOADING A NEW REAGENT CASSETTE. 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 (B)(6) 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.

    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
    1 027 YR