BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA CALCIUM

    MDR report key: 1844345 · Received September 24, 2010

    Report

    Report Number
    1823260-2010-05698
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 20, 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
    IL, 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 INFORMATION THAT THIS PATIENT WITH ATRIAL FIBRILLATION, CHEST PAIN AND A SIGNIFICANT AMOUNT OF PREMATURE VENTRICULAR CONTRACTIONS (PVC) HAD RIGHT VENTRICULAR (RV) LEAD OVERSENSING NOTED WITH PACING INHIBITION OF THREE TO FOUR SECONDS. THE PHYSICIAN WANTED TO PROGRAM THE DEVICE TO VOO MODE AND TECHNICAL SERVICES (TS) NOTED THAT THIS WAS NOT A FEATURE FOR THIS MODEL. TS RECOMMENDED CHANGING THE DEVICE SENSING TO MIMIC VOO PACING.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE HIGH CALCIUM RESULTS FOR SEVEN PATIENT SAMPLES FROM THE INTEGRA 400, SERIAL NUMBER (B)(4). THE USER REMOVED THE REAGENT CASSETTE, LOADED A NEW REAGENT CASSETTE, CALIBRATED AND RAN QUALITY CONTROL. THE PATIENT SAMPLES WERE THEN REPEATED. ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 11.2 WITH A DATA FLAG, REPEAT RESULT WAS 9.9. PATIENT SAMPLE 2 FROM A (B)(6) FEMALE PATIENT, BORN ON (B)(6), INITIAL RESULT WAS 11.8 WITH A DATA FLAG, REPEAT RESULT WAS 10.2. PATIENT SAMPLE 3 FROM A (B)(6) MALE PATIENT, BORN ON (B)(6), INITIAL RESULT WAS 12.4 WITH A DATA FLAG, REPEAT RESULT WAS 9.9. PATIENT SAMPLE 4 FROM A (B)(6) FEMALE PATIENT, BORN ON (B)(6), INITIAL RESULT WAS 11.0 WITH A DATA FLAG, REPEAT RESULT WAS 10.1. PATIENT SAMPLE 5 FROM A (B)(6) FEMALE PATIENT, BORN ON (B)(6), INITIAL RESULT WAS 11.7 WITH A DATA FLAG, REPEAT RESULT WAS 9.3. PATIENT SAMPLE 6 FROM A (B)(6) MALE PATIENT, BORN ON (B)(6), INITIAL RESULT WAS 12.5 WITH A DATA FLAG, REPEAT RESULT WAS 9.5. PATIENT SAMPLE 7 FROM A (B)(6) FEMALE PATIENT, BORN ON (B)(6), INITIAL RESULT WAS 13.1 WITH A DATA FLAG, REPEAT RESULT WAS 9.7. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THE REPORTS WERE CORRECTED WITHIN A FEW HOURS. THE USER STATED SHE WAS SURE THE PATIENTS WERE NOT AFFECTED BECAUSE THE PHYSICIANS WOULD NOT HAVE HAD TIME TO REVIEW THE REPORTS AND CHANGE TREATMENT BEFORE THE CORRECTED REPORTS WERE ISSUED. THE USER STATED ONLY ONE PHYSICIAN SIGNED OFF ON THE INITIAL REPORT AND HAD NOT TAKEN ANY ACTION BEFORE THE CORRECTED REPORT WAS AVAILABLE. THE CALCIUM REAGENT LOT NUMBER WAS 62601901. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A BAD CONSUMABLE REAGENT PACK AND REPLACED THE REAGENT PACK. TO VERIFY THE ANALYZER OPERATION, THE USER RAN CALIBRATION, QUALITY CONTROL AND PRECISION TESTING WITH RESULTS WITHIN SPECIFICATIONS.

    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
    1 037 YR