BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA CALCIUM

    MDR report key: 1843389 · Received September 24, 2010

    Report

    Report Number
    1823260-2010-05672
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    September 10, 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
    PA, 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 CUSTOMER RECEIVED QUESTIONABLE CALCIUM PATIENT RESULTS MULTIPLE TIMES DURING THE MIDNIGHT SHIFT. SHE PROVIDED CALCIUM RESULTS FOR 54 PATIENTS, RESULTS FOR FIVE OF THE PATIENTS WERE DISCREPANT. PATIENT 1, ORIGINAL RESULT WAS 9.5 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WHEN REPEATED, RECOVERED 8.7 MG/DL. PATIENT 2, ORIGINAL RESULT WAS 10.1 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WHEN REPEATED, RECOVERED 8.9 MG/DL. PATIENT 3, ORIGINAL RESULT WAS 10.1 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WHEN REPEATED, RECOVERED 9.3 MG/DL. PATIENT 4, ORIGINAL RESULT WAS 10.0 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WHEN REPEATED, RECOVERED 9.1 MG/DL. PATIENT 5, ORIGINAL RESULT WAS 11.5 MG/DL (ACCOMPANIED BY A DATA FLAG) AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WHEN REPEATED, RECOVERED 10.7 MG/DL. THE CALCIUM REPEAT RESULTS WERE GENERATED FROM THIS COBAS 6000 C501 ANALYZER OR ANOTHER COBAS 6000 C501 ANALYZER (SERIAL NUMBER (B)(4)). IT IS UNKNOWN WHICH SAMPLES WERE REPEATED ON EACH ANALYZER. THE PATHOLOGIST REVIEWED THE CALCIUM RESULTS AND DETERMINED THE DIFFERENCES BETWEEN THE ORIGINAL AND REPEAT VALUES WERE NOT CLINICALLY SIGNIFICANT. THEY DID NOT SEND OUT ANY CORRECTED RESULTS. THE CUSTOMER HAS NO KNOWLEDGE THAT ANY PATIENT WAS ADVERSELY AFFECTED OR TREATED BASED ON THE CALCIUM RESULTS THAT WERE REPORTED. THE CALCIUM REAGENT LOT NUMBER WAS 62601901. THE FIELD SERVICE REPRESENTATIVE DETERMINED FLUIDIC FAILURE OF THE VACUUM WASTE SYSTEM CAUSED THE DISCREPANCIES. HE PERFORMED CORRECTIVE MAINTENANCE AND REMOVED THE RESTRICTION FROM THE VACUUM WASTE VESSEL FITTINGS. HE ALSO FOUND FLUIDIC FAILURE OF THE SAMPLE SYSTEM LEAD TO THIS ISSUE AND REPLACED A VALVE ASSEMBLY. THE FIELD SERVICE REPRESENTATIVE RAN MECHANISM CHECKS AND A CALCIUM PRECISION STUDY TO VERIFY PROPER ANALYZER OPERATION. HE ALSO RAN CALCIUM CALIBRATION AND QUALITY CONTROL WHICH WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THERE WAS AN INCREASED FORCE TO FIRE THE DEVICE ON THE THIRD OR FOURTH FIRING. ONE SIDE OF THE STAPLE LINE DID NOT HAVE FULLY FORMED STAPLES THIS ALSO HAPPENED ON THE THIRD OR FOURTH FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. NO DEVICE WILL BE RETURNED AT THIS TIME. (B)(4)

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1