BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA CALCIUM

    MDR report key: 1871452 · Received October 15, 2010

    Report

    Report Number
    1823260-2010-06164
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 22, 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
    MA, 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

    THE USER DISCOVERED QUESTIONABLE CALCIUM RESULTS HAD BEEN GENERATED FROM THE INTEGRA 800 SERIAL NUMBER (B)(4) WHEN TWO PHYSICIANS CALLED CONCERNING HIGH RESULTS. ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 11.0, REPEAT RESULT ON (B)(6) 2010 WAS 9.9. PATIENT SAMPLE 2 INITIAL RESULT WAS 10.6, REPEAT RESULT ON (B)(6) 2020 WAS 9.8. THE USER SENT CORRECTED REPORTS AND THE PATIENTS WERE NOT TREATED OR IMPACTED DUE TO THE ERRONEOUS RESULTS. THE USER THEN PULLED ALL PATIENT SAMPLES WITH HIGH CALCIUM RESULTS AND REPEATED TESTING. OF THE DATA PROVIDED, THE RESULTS FOR 45 ADDITIONAL PATIENT SAMPLES WERE DISCREPANT. ALL REPEAT TESTING WAS PERFORMED ON (B)(6) 2010. THESE PATIENTS WERE INITIALLY TESTED ON (B)(6) 2010 PATIENT SAMPLE 3 INITIAL RESULT WAS 11.6, REPEAT RESULT WAS 10.6. PATIENT SAMPLE 4 INITIAL RESULT WAS 11.8, REPEAT RESULT WAS 10.7. PATIENT SAMPLE 5 INITIAL RESULT WAS 10.8, REPEAT RESULT WAS 9.5. PATIENT SAMPLE 6 INITIAL RESULT WAS 11.7, REPEAT RESULT WAS 9.9. PATIENT SAMPLE 7 INITIAL RESULT WAS 11.1, REPEAT RESULT WAS 10.1. PATIENT SAMPLE 8 INITIAL RESULT WAS 10.8, REPEAT RESULT WAS 9.6. PATIENT SAMPLE 9 INITIAL RESULT WAS 11.5, REPEAT RESULT WAS 10.2. PATIENT SAMPLE 10 INITIAL RESULT WAS 11.4, REPEAT RESULT WAS 10.4. THESE PATIENTS WERE INITIALLY TESTED ON (B)(6) 2010. PATIENT SAMPLE 11 INITIAL RESULT WAS 10.8, REPEAT RESULT WAS 9.3. PATIENT SAMPLE 12 INITIAL RESULT WAS 10.7, REPEAT RESULT WAS 9.7. PATIENT SAMPLE 13 INITIAL RESULT WAS 11.0, REPEAT RESULT WAS 9.9. PATIENT SAMPLE 14 INITIAL RESULT WAS 10.9, REPEAT RESULT WAS 9.4. PATIENT SAMPLE 15 INITIAL RESULT WAS 11.1, REPEAT RESULT WAS 9.8. PATIENT SAMPLE 16 INITIAL RESULT WAS 10.6, REPEAT RESULT WAS 9.6. PATIENT SAMPLE 17 INITIAL RESULT WAS 11.4, REPEAT RESULT WAS 9.7. PATIENT SAMPLE 18 INITIAL RESULT WAS 11.6, REPEAT RESULT WAS 10.4. PATIENT SAMPLE 19 INITIAL RESULT WAS 11.3, REPEAT RESULT WAS 10.3. PATIENT SAMPLE 20 INITIAL RESULT WAS 11.4, REPEAT RESULT WAS 9.6. PATIENT SAMPLE 21 INITIAL RESULT WAS 11.3, REPEAT RESULT WAS 9.9. PATIENT SAMPLE 22 INITIAL RESULT WAS 10.9, REPEAT RESULT WAS 9.1. PATIENT SAMPLE 23 INITIAL RESULT WAS 10.8, REPEAT RESULT WAS 9.8. PATIENT SAMPLE 24 INITIAL RESULT WAS 11.1, REPEAT RESULT WAS 9.6. PATIENT SAMPLE 25 INITIAL RESULT WAS 11.1, REPEAT RESULT WAS 10.0. PATIENT SAMPLE 26 INITIAL RESULT WAS 11.0, REPEAT RESULT WAS 10.0. PATIENT SAMPLE 27 INITIAL RESULT WAS 10.9, REPEAT RESULT WAS 9.9. PATIENT SAMPLE 28 INITIAL RESULT WAS 10.7, REPEAT RESULT WAS 9.7. PATIENT SAMPLE 29 INITIAL RESULT WAS 11.4, REPEAT RESULT WAS 10.5. PATIENT SAMPLE 30 INITIAL RESULT WAS 11.0, REPEAT RESULT WAS 9.8. PATIENT SAMPLE 31 INITIAL RESULT WAS 11.0, REPEAT RESULT WAS 9.9. PATIENT SAMPLE 32 INITIAL RESULT WAS 10.6, REPEAT RESULT WAS 9.6. PATIENT SAMPLE 33 INITIAL RESULT WAS 11.7, REPEAT RESULT WAS 10.2. PATIENT SAMPLE 34 INITIAL RESULT WAS 10.9, REPEAT RESULT WAS 10.0. PATIENT SAMPLE 35 INITIAL RESULT WAS 10.7, REPEAT RESULT WAS 9.4. THESE PATIENTS WERE INITIALLY TESTED ON (B)(6) 2010. PATIENT SAMPLE 36 INITIAL RESULT WAS 10.8, REPEAT RESULT WAS 9.7. PATIENT SAMPLE 37 INITIAL RESULT WAS 10.9, REPEAT RESULT WAS 9.7. PATIENT SAMPLE 38 INITIAL RESULT WAS 10.9, REPEAT RESULT WAS 9.8. PATIENT SAMPLE 39 INITIAL RESULT WAS 10.7, REPEAT RESULT WAS 9.2. PATIENT SAMPLE 40 INITIAL RESULT WAS 11.1, REPEAT RESULT WAS 10.3. THIS PATIENT WAS INITIALLY TESTED ON (B)(6) 2010. PATIENT SAMPLE 41 INITIAL RESULT WAS 10.8, REPEAT RESULT WAS 9.7. THESE PATIENT SAMPLES WERE INITIALLY TESTED ON (B)(6) 2010. PATIENT SAMPLE 42 INITIAL RESULT WAS 10.6, REPEAT RESULT WAS 9.4. PATIENT SAMPLE 43 INITIAL RESULT WAS 12.1, REPEAT RESULT WAS 10.2. PATIENT SAMPLE 44 INITIAL RESULT WAS 11.2, REPEAT RESULT WAS 9.8. PATIENT SAMPLE 45 INITIAL RESULT WAS 11.1, REPEAT RESULT WAS 9.4. PATIENT SAMPLE 46 INITIAL RESULT WAS 10.7, REPEAT RESULT WAS 9.8. PATIENT SAMPLE 47 INITIAL RESULT WAS 11.1, REPEAT RESULT WAS 10.0. THE USER STATED NO PATIENTS WERE TREATED BASED ON THE INITIAL RESULTS AS SHE HAD SENT AN EMAIL TO THE PHYSICIANS INFORMING THEM THERE WAS AN ISSUE WITH CALCIUM RECOVERY AND CORRECTED REPORTS WOULD BE FORTHCOMING. NONE OF THE PHYSICIANS ACTED UPON THE INITIAL RESULTS. THE FIELD SERVICE REPRESENTATIVE SUSPECTED THE REAGENT WAS THE CAUSE OF THE ELEVATED RESULTS. HE PERFORMED PREVENTATIVE MAINTENANCE AND REPLACED VARIOUS PARTS. TO VERIFY THE ANALYZER OPERATION, HE PERFORMED CALCIUM CALIBRATION, QUALITY CONTROL AND PRECISION TESTING WITH ACCEPTABLE RESULTS.

    Description of Event or Problem · 1

    CONSUMER STATED THE TIP OF THE TAMPON BROKE OFF WHEN SHE REMOVED IT FROM HER BODY. SHE ATTEMPTED TO REMOVE THE REMAINING PIECE AND THE PIECE CAME OUT IN CLUMPS.

    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