BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA CALCIUM

    MDR report key: 1852262 · Received October 4, 2010

    Report

    Report Number
    1823260-2010-05857
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 14, 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 SIX PATIENT SAMPLES FROM THE INTEGRA 800 SERIAL NUMBER (B)(4). OF THE PROVIDED DATA, THE RESULTS FOR FIVE PATIENT SAMPLES WERE DISCREPANT. ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 12.7 WITH A DATA FLAG, REPEAT RESULTS WERE 9.8 WITH A DATA FLAG AND 9.0 AFTER THE REAGENT CASSETTE WAS CHANGED. PATIENT SAMPLE 2 INITIAL RESULT WAS 11.7 WITH A DATA FLAG, REPEAT RESULTS WERE 11.3 WITH A DATA FLAG AND 9.0 AFTER THE REAGENT CASSETTE WAS CHANGED. THE SAMPLE WAS REPEATED ON INTEGRA 800 SERIAL NUMBER (B)(4) AND THE RESULT WAS 8.8. PATIENT SAMPLE 3 INITIAL RESULT WAS 12.9 WITH A DATA FLAG, REPEAT RESULT ON INTEGRA 800 SERIAL NUMBER (B)(4) WAS 9.8. PATIENT SAMPLE 4 INITIAL RESULT WAS 12.7 WITH A DATA FLAG, REPEAT RESULTS WERE 8.6 WITH A DATA FLAG AND 8.5. PATIENT SAMPLE 5 INITIAL RESULT WAS 12.1 WITH A DATA FLAG, REPEAT RESULT ON INTEGRA 800 SERIAL NUMBER (B)(4) WAS 8.8. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. NO PATIENTS WERE ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE. HE STATED THE CALCIUM ASSAY WAS RUNNING ACCEPTABLY UPON HIS ARRIVAL AT THE SITE BASED ON THE PATIENT RESULTS AND THE USER'S QUALITY CONTROL RESULTS WITHIN SPECIFICATION.

    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