BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C111

    MDR report key: 1620185 · Received March 3, 2010

    Report

    Report Number
    1823260-2010-01357
    Event Type
    Malfunction
    Date Received
    March 3, 2010
    Date of Event
    February 8, 2010
    Report Date
    April 28, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K071211
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Additional Manufacturer Narrative · 1

    BASED UPON THE INFORMATION PROVIDED, IT WAS DETERMINED MOST LIKELY INCORRECT PRE- ANALYTIC HANDLING OF SAMPLES IN COMBINATION WITH INSUFFICIENT PRODUCT MAINTENANCE CAUSED THE EVENT. THE CUSTOMER REPORTED NO PATIENTS HAD BEEN TREATED BASED ON THE ORIGINAL RESULTS AND THE PHYSICIAN ASKED FOR FOLLOW-UP TESING.

    Description of Event or Problem · 1

    CUSTOMER HAD LOW SODIUM PATIENT RESULTS FOR A FEW DAYS. CUSTOMER BECAME AWARE OF ISSUE WHEN THE CLINICAL DIRECTOR QUESTIONED THE SODIUM RESULTS. SHE SENT THREE SAMPLES TO THE HOSPITAL FOR REPEATED ANALYSIS: PATIENT 1, INITIAL SODIUM RESULT 123, REPEAT AT HOSPITAL ON (B) (6)2010, 133 MMOL/L. PATIENT 2, INITIAL SODIUM RESULT 127, REPEAT AT HOSPITAL ON 2/9/10, 137 MMOL/L. PATIENT 3, INITIAL SODIUM RESULT 128, REPEAT AT HOSPITAL ON (B) (6)2010, 139 MMOL/L. THE FIELD SERVICE REPRESENTATIVE REPEATED A SAMPLE, (B) (6)2010, WHILE ON SITE: PATIENT 4, INITIAL SODIUM RESULT 128, REPEAT 138 MMOL/L. CUSTOMER HAD TWO SAMPLES SHE REPEATED AND ISSUED CORRECTIVE REPORTS, SHE DECLINED TO PROVIDE ACTUAL RESULTS. NO PATIENTS HAD BEEN TREATED BASED ON THE ORIGINAL RESULTS, THE DOCTOR ASKED FOR FOLLOW-UP TESTING. SODIUM ELECTRODE LOT WAS 21593711. THE FIELD SERVICE REPRESENTATIVE COULD NOT RECREATE THE ISSUE. HE CLEANED WASTE TANK, CHECKED PINCH VALVES AND TUBING FOR ANY PROBLEMS. THE FIELD SERVICE REPRESENTATIVE RAN CALIBRATION, QC AND A PRECISION. ALL WERE ACCEPTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS BEING REPLACED AFTER LESS THAN 5 YEARS IMPLANT DURATION. A "FAILED" LEAD (RECALLED LEAD THAT WAS FRACTURED AND OVERSENSING WITH SHOCKS) WAS BEING EXTRACTED WITH A LASER. WHEN THE LEAD WAS APPROXIMATELY HALF WAY EXTRACTED, PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND IT WAS DETERMINED THE PATIENT HAD A PERICARDIAL TAMPONADE. AT THAT TIME, A PERICARDIOCENTESIS WAS PERFORMED, A SURGEON WAS CALLED, AND THE PATIENT WAS TAKEN TO SURGERY WHERE IT WAS REPORTED, SHE DIED. FOLLOW UP WITH MANUFACTURER'S REPRESENTATIVE REPORTED THE CAUSE OF DEATH IS UNKNOWN AND PRIOR TO LEAD EXTRACTION, THE PATIENT WAS STABLE. THE MANUFACTURER'S REPRESENTATIVE DOES NOT BELIEVE THE PATIENT'S DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS C111 CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1