BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3844089 · Received June 2, 2014

    Report

    Report Number
    1823260-2014-03940
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 3, 2014
    Report Date
    August 13, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Description of Event or Problem · 1

    PATIENT REPORTED FACING E6 (MECHANICAL ERRORS ALONG WITH UNEXPLAINED HIGH AND LOW BLOOD GLUCOSE READINGS. PATIENT STATED HE IS UNSURE IF THE PUMP IS FUNCTIONING PROPERLY. PATIENT REPORTED THAT FOR THE LAST 2 WEEKS, EVERY 3 DAYS OR SO, THE PUMP DISPLAYS THE E6 (MECHANICAL ERROR) MESSAGE. PATIENT STATED HE CHANGED THE INSULIN CARTRIDGE AND THIS CLEARS THE ERROR. PATIENT REPORTED HE THINKS INSULIN HAS GOTTEN IN THE CHAMBER OF THE PUMP; PATIENT DOES NOT ATTACH THE ADAPTER AND TUBING TO THE CARTRIDGE PRIOR TO INSERTING CARTRIDGE IN THE PUMP. PATIENT STATED HE THINKS INSULIN MAY BE SPILLING OUT OF THE TOP OF THE CARTRIDGE UPON INSERTING THE CARTRIDGE IN THE CHAMBER OF THE PUMP. PATIENT STATES THE ADAPTER HAS BEEN IN USE FOR AT LEAST ONE YEAR IN PSITE OF LABELING TO ROUTINELY CHANGE IT. PATIENT REPORTED HE WOKE UP WITH A BLOOD GLUCOSE LEVEL OF 478 MG/DL ON (B)(6) 2014; HE BOLUSED FOR THE READING AND THEN 3½ HOURS LATER HIS READING WAS 380 MG/DL. PATIENT STATED HE FELT LIKE HE WAS NOT GETTING ANY INSULIN SO HE TOOK AN INJECTION AND THE READING CAME DOWN. PATIENT REPORTED THAT AT 4 PM HE HAD A LIGHT DINNER OF SALAD AND BOLUSED; READING WENT UP TO 350 MG/DL. PATIENT STATED AT BEDTIME HIS READING WAS 315 MG/DL AND HE TOOK A BOLUS. PATIENT REPORTED THAT AT 4 AM ON (B)(6) 2014 HIS READING WAS 240 MG/DL; HE BLOUSED FOR THAT READING AND AT 8 AM HIS BLOOD GLUCOSE WENT DOWN TO 32 MG/DL. PATIENT STATED HE WAS ABLE TO DRINK JUICE WHICH HE WAS ABLE TO OBTAIN HIMSELF; NO OUTSIDE ASSISTANCE WAS REQUIRED. PATIENT REPORTED HE SWITCHED TO HIS BACKUP PUMP AT 12 PM AND HIS BLOOD GLUCOSE LEVEL WENT UP TO 220 MG/DL BUT STABILIZED AFTER BOLUSING ON THAT PUMP. PATIENT'S CURRENT BLOOD GLUCOSE READING IS 170 MG/DL AFTER HE HAD JUST EATEN. PATIENT STATED HE DOES NOT FEEL THE PRIMARY PUMP IS WORKING PROPERLY BUT IS CONFIDENT THE BACKUP PUMP IS WORKING PROPERLY. PATIENT REPORTED HE WAS STARTED ON AN ANTIBIOTIC ONE WEEK AGO. NO ADVERSE EVENT REPORTED. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322084 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1