BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA CALCIUM

    MDR report key: 1872795 · Received October 18, 2010

    Report

    Report Number
    1823260-2010-06175
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ROCHE DIAGNOSTICS CORPORATION
    Product Code
    CIC
    PMA / PMN Number
    K963292
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT POST XACT STENT IMPLANTATION IN THE RIGHT INTERNAL CAROTID ARTERY, THE PT EXPERIENCED HYPOTENSION AND WAS TREATED WITH FLUIDS AND LEVOPHED. AT APPROXIMATELY 10 PM THAT EVENING, THE PT EXPERIENCED A DROP IN BLOOD PRESSURE AND REPORTED FEELING ANXIOUS AND SHORT OF BREATH. SHORTLY AFTER, THE PT EXPERIENCED RESPIRATORY ARREST AND WAS INTUBATED. HEART RHYTHM WAS IN PULSELESS ELECTRICAL ACTIVITY (PEA). CARDIOPULMONARY RESUSCITATION WAS INITIATED FOR 12 MINUTES. THE PT EXHIBITED NO RESPIRATORY EFFORT, REMAINED IN PEA AND PUPILS WERE FIXED AND DILATED. THE CODE WAS CALLED AT 10:42 PM AND THE PT WAS PRONOUNCED DEAD. PER PHYSICIAN, THE DEATH WAS NOT DEVICE RELATED, BUT POSSIBLY FROM A MYOCARDIAL INFARCTION OR PULMONARY EMBOLISM. THERE WAS NO ADD'L INFO PROVIDED.

    Description of Event or Problem · 1

    THE USER RECEIVED ERRONEOUS CALCIUM RESULTS FOR THREE PATIENT SAMPLES FROM THE INTEGRA 800 THAT WERE QUESTIONED BY THE PHYSICIAN. ALL RESULTS ARE IN MG/DL. THE REPEAT TESTING WAS PERFORMED ON (B)(6) 2010. PATIENT SAMPLE 1 INITIAL RESULT WAS 11.0 AND THE REPEAT RESULT WAS 9.5. PATIENT SAMPLE 2 FROM A (B)(6) FEMALE, INITIAL RESULT WAS 11.4 AND THE REPEAT RESULT WAS 9.7. PATIENT SAMPLE 3 FROM A (B)(6) FEMALE, INITIAL RESULT WAS 11.4 AND THE REPEAT RESULT WAS 9.6. THE PATIENTS WERE NOT AFFECTED DUE TO THE EVENT. THE CACLIUM REAGENT LOT NUMBER WAS 62601901. THE FIELD SERVICE REPRESENTATIVE CHECKED THE SYSTEM AND COULD NOT FIND A HARDWARE PROBLEM. HE PERFORMED DIAGNOSTIC AND PIPETTING CHECKS AND VERIFIED THE ANALYZER WITH THE EXPECTED RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR