BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA CALCIUM

    MDR report key: 1860586 · Received October 7, 2010

    Report

    Report Number
    1823260-2010-05985
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 16, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIC
    PMA / PMN Number
    K951595
    Removal / Correction Number
    1823260-09/27/10-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    THE FIELD APPLICATION SPECIALIST REPORTED THE USER RECEIVED QUESTIONABLE CALCIUM RESULTS FROM THE INTEGRA 400 THAT WERE DISCOVERED WHEN A DOCTOR QUESTIONED THE HIGH RESULT FOR ONE PATIENT. FOR PATIENT SAMPLE 1, THE USER REPORTED AN INITIAL RESULT OF 11.2 MG/DL WITH A DATA FLAG. THE PATIENT WAS REDRAWN AND THE RESULT WAS 9.3 MG/DL. THE USER THEN PULLED THE ORIGINAL PATIENT SAMPLE AND REPEATED IT WITH A RESULT OF 9.6 MG/DL. PATIENT SAMPLE 2 WAS FROM A MALE PATIENT BORN ON (B)(6) WITH A WEIGHT OF (B)(6) ON (B)(6) 2010. THE INITIAL RESULT WAS 12.6 MG/DL WITH A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS REDRAWN AND THE RESULT WAS 10.2 MG/DL THE USER THEN PULLED THE ORIGINAL PATIENT SAMPLE AND REPEATED IT WITH A RESULT OF 10.2 MG/DL. PATIENT SAMPLE 3 WAS FROM A MALE PATIENT BORN ON (B)(6) WITH A WEIGHT OF (B)(6) ON (B)(6) 2010. THE INITIAL RESULT WAS 11.2 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY AND THE REPEAT RESULT WAS 8.8 MG/DL. PATIENT SAMPLE 4 WAS FROM A MALE PATIENT BORN ON (B)(6) WITH A WEIGHT OF (B)(6) ON (B)(6) 2010. THE INITIAL RESULT WAS 10.9 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS 9.1 MG/DL. THE USER HAD NOT BEEN INFORMED OF ANY ADVERSE EFFECTS FOR THE PATIENTS. THE CALCIUM REAGENT LOT NUMBER WAS 62601901. THE FIELD SERVICE REPRESENTATIVE FOUND A DAMAGED PROBE C. HE CHECKED AND ADJUSTED THE ROTOR LIGHT BARRIER, PERFORMED A WORKSTATION ACCURACY CHECK, PERFORMED A CHECK TEST AND REPLACED PROBE C. TO VERIFY THE ANALYZER OPERATION, HE OBSERVED PROPER ANALYZER FUNCTION WHILE THE USER RAN CALIBRATION AND QUALITY CONTROL. ALL THE QUALITY CONTROL RESULTS WERE WITHIN RANGE. HE PERFORMED A SUCCESSFUL CHECK TEST AND PRECISION TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXCESSIVE FRICTION WAS ENCOUNTERED WITH THE GUIDE/SHEATH OR MICRO SHEATH. REPORTEDLY, THE TIP OF THE RECANALIZATION CATHETER DETACHED FROM THE REST OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA CALCIUM CRESOLPHTHALEIN COMPLEXONE, CALCIUM CIC ROCHE DIAGNOSTICS 62601901

    Patients

    Seq Age Sex Outcome Treatment
    1 049 YR