BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA CALCIUM

    MDR report key: 2010983 · Received March 8, 2011

    Report

    Report Number
    1823260-2011-01251
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 17, 2011
    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
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE CALCIUM RESULTS AND PROVIDED DATA FOR EIGHTEEN PATIENT SAMPLES. OF THE DATA PROVIDED, THE RESULTS FOR THREE SAMPLES WERE DISCREPANT. AFTER THE INITIAL RESULTS WERE GENERATED, THE USER RAN QUALITY CONTROL WHICH WAS OUT OF THE ACCEPTABLE RANGE. THE USER REPLACED THE REAGENT CASSETTE, PERFORMED CALIBRATION AND QUALITY CONTROL THEN REPEATED TESTING OF THE PATIENT SAMPLES. ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 11.3 WITH A DATA FLAG, REPEAT RESULT WAS 9.1. PATIENT SAMPLE 2 INITIAL RESULT WAS 10.7 WITH A DATA FLAG, REPEAT RESULT WAS 8.7. PATIENT SAMPLE 3 INITIAL RESULT WAS 11.3 WITH A DATA FLAG, REPEAT RESULT WAS 9.1. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND CORRECTED REPORTS WERE SENT FOR THE THREE PATIENT SAMPLES. THE USER STATED SHE WAS NOT AWARE OF ANY ADVERSE IMPACT TO ANY PATIENT OR OF ANY PATIENT BEING TREATED BASED ON THE ERRONEOUS CALCIUM RESULT. THE CALCIUM REAGENT LOT NUMBER WAS 63020401. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE SYSTEM NEEDED TO BE DECONTAMINATED. HE DECONTAMINATED THE FLUIDIC SYSTEM AND REPLACED THE FILTER. TO VERIFY THE ANALYZER OPERATION, HE PERFORMED SYRINGE CHECKS AND PRECISION TESTING.

    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