BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA CALCIUM

    MDR report key: 1850953 · Received October 4, 2010

    Report

    Report Number
    1823260-2010-05851
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 8, 2010
    Report Date
    October 22, 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
    MN, 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

    A REPORT WAS RECEIVED THAT THE CLINICIAN WAS A PERFORMING AN ABG DRAW AND WAS SPLASHED BY BLOOD. REPORTEDLY THE TECHNICIAN REMOVED THE CANNULA AND WAS ATTEMPTING EXPEL AIR THROUGH A FILTERED ENDCAP WHEN THE LUER BROKE SPLASHING BLOOD IN THE TECHNICIAN FACE.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR CALCIUM ON THE INTEGRA 400 PLUS ANALYZER, SERIAL NUMBER (B)(4). THE EVENT INVOLVED TWO PATIENT SAMPLES WHICH GAVE DISCREPANT RESULTS. PATIENT SAMPLE 1, THE INITIAL CALCIUM RESULT WAS 10.8 MG/DL. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED FOUR TIMES GIVING 9.6, 10.2, 9.0 AND 8.9 MG/DL. THE USER RAN TWO DIFFERENT ALIQUOTS TAKEN FROM THE SAME SAMPLE WHICH YIELDED CALCIUM RESULTS OF 8.5 AND 8.6 MG/DL RESPECTIVELY. A SECOND SAMPLE COLLECTED FROM THE PATIENT THE SAME DAY WAS TESTED TWICE GIVING A CALCIUM RESULTS OF 9.5 AND 9.0 MG/DL RESPECTIVELY. THE USER CORRECTED THE INITIAL CALCIUM RESULT REPORTED OUTSIDE THE LABORATORY WITH THE CALCIUM RESULT OF 9.5 MG/DL. PATIENT SAMPLE 2, FEMALE, DATE OF BIRTH OF (B)(6). ON (B)(6) 2010 THE INITIAL CALCIUM RESULT GAVE 11.4 MG/DL. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY. THE USER RAN TWO DIFFERENT ALIQUOTS TAKEN FROM THE SAME SAMPLE WHICH YIELDED CALCIUM RESULTS OF 10.5 AND 10.4 MG/DL RESPECTIVELY. THE REPEAT CALCIUM RESULT OF 10.5 MG/DL WAS ACCOMPANIED BY A DATA FLAG. A SECOND SAMPLE COLLECTED FROM THE PATIENT THE SAME DAY WAS TESTED TWICE GIVING CALCIUM RESULTS OF 10.8 AND 10.7 MG/DL. BOTH CALCIUM RESULTS FROM THIS SECOND SAMPLE WERE ACCOMPANIED BY DATA FLAGS. NO ADVERSE EVENT HAS BEEN ALLEGED REGARDING THESE DISCREPANCIES. THE FIELD SERVICE REPRESENTATIVE (FSR) COULD NOT FIND A CAUSE OR DUPLICATE THE ISSUE. AS A PRECAUTION WATER SAMPLES FROM THE INTERNAL AND EXTERNAL WATER RESERVOIRS WERE TAKEN AND TESTED BY THE LABORATORY. THE FSR RAN PERFORMANCE TESTS WHICH WERE ACCEPTABLE TO THE CUSTOMER AND WITHIN SPECIFICATION.

    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
    1 079 YR