BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA CALCIUM

    MDR report key: 2027303 · Received March 23, 2011

    Report

    Report Number
    1823260-2011-01566
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 23, 2011
    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
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE CALCIUM RESULTS FOR ONE PATIENT SAMPLE. THE INITIAL CALCIUM RESULT WAS 4.05 MMOL/L (ACCOMPANIED BY A DATA FLAG) AND WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN CONTACTED THE LABORATORY BECAUSE THE PATIENT WAS ASYMPTOMATIC. NO TREATMENT WAS GIVEN, HOWEVER, THE PATIENT WAS IMMEDIATELY SENT TO ANOTHER CLINIC TO BE REDRAWN FOR A SECOND SAMPLE. ON (B)(6) 2011, THE SECOND SAMPLE WAS TESTED AND GENERATED A CALCIUM RESULT OF 2.10 MMOL/L. ON (B)(6) 2011, THE ORIGINAL SAMPLE WAS REPEATED AND GENERATED A RESULT OF 2.44 MMOL/L. THE PATIENT WAS NOT HARMED BY THE EVENT. THE ANALYZER INVOLVED WAS A COBAS 6000 C501 MODULE, SERIAL NUMBER (B)(4). THE CUSTOMER'S REAGENT CASSETTE WAS NO LONGER AVAILABLE, HOWEVER THE INVESTIGATION DETERMINED THE CAUSE OF THE DISCREPANCIES COULD BE ATTRIBUTED TO THE PRECIPITATE IN THE REAGENT. INTERNAL INVESTIGATIONS OF CUSTOMER REAGENTS REVEALED THE PRESENCE OF PRECIPITATE IN THE R2 OF AFFECTED CALCIUM REAGENT LOTS. THE ROOT CAUSE FOR THE PRECIPITATION IS STILL UNDER INVESTIGATION. AN URGENT MEDICAL DEVICE REMOVAL NOTICE HAS BEEN MAILED WHICH PROVIDES USERS WITH INSTRUCTIONS FOR PRODUCT REPLACEMENT AND FOR APPROPRIATE HANDLING OF ALL OTHER CURRENT CALCIUM REAGENT LOTS. THE NEXT CALCIUM PRODUCTION LOT IS CURRENTLY BEING MANUFACTURED WITH MODIFIED PH-VALUES TO IMPROVE THE SOLUBILITY OF O-CPC IN THE R2 SOLUTION. INACCURATELY HIGH SERUM/PLASMA 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 (>3 MMOL/L). URINE CALCIUM TESTS CAN BE DONE AS AN AID IN DIAGNOSIS OF NEPHROLITHIASIS (KIDNEY STONE) WHICH MAY HAVE DEVELOPED BASED ON ELEVATED AMOUNTS OF CALCIUM IN THE URINE AND AS AID IN DIAGNOSIS FOR PARATHYROID GLANDS DISORDERS. A URINE CALCIUM TEST IS NOT AS HELPFUL AS A SERUM/PLASMA CALCIUM TEST FOR DIAGNOSIS OF CERTAIN CONDITIONS, SUCH AS BONE DISEASES OR PANCREATITIS. ERRONEOUSLY ELEVATED PATIENT RESULTS FOR URINE CALCIUM ARE NOT CONSIDERED MEDICALLY CRITICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA CALCIUM CRESOLPHTHALEIN COMPLEXONE, CALCIUM CIC ROCHE DIAGNOSTICS NA 63020401

    Patients

    Seq Age Sex Outcome Treatment
    1 080 YR