BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3941165 · Received July 17, 2014

    Report

    Report Number
    1823260-2014-05298
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 5, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 HER BLOOD GLUCOSE LEVEL BECAME ELEVATED 2 WEEKS AGO AND SHE BELIEVES THE PUMP IS NOT DELIVERING ENOUGH INSULIN. PATIENT STATED SHE BEGAN NOTICING E4 (OCCLUSION) ERROR MESSAGES ON THE PUMP; SHE WOULD CHANGE THE CARTRIDGE AND INFUSION SET AND IT WOULD WORK FOR A SHORT TIME AND THEN THE OCCLUSION WOULD START AGAIN. PATIENT REPORTED THAT LAST WEEK APPROXIMATELY (B)(6) 2014, HER BLOOD GLUCOSE WAS 600 MG/DL. PATIENT STATED SHE CHANGED THE CARTRIDGE AND INFUSION SET THEN USED AN INSULIN INJECTION; BLOOD GLUCOSE LOWERED TO 300 MG/DL BUT WENT BACK UP NEAR 600 MG/DL. PATIENT REPORTED SHE SWITCHED TO THE BACKUP PUMP; DID NOT USE THE SAME ACCESSORIES. PATIENT STATED HER BLOOD GLUCOSE LEVEL RETURNED TO NORMAL WHEN SHE SWITCHED TO THE BACKUP PUMP AND REMAINED NORMAL SINCE THEN. PATIENT DISCARDED THE ADAPTER, CARTRIDGES AND INFUSION SETS. NO ADVERSE EVENT REPORTED. PRODUCT WAS REPLACED AND REQUESTED ALLEGED PUMP FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419706 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN - BRAND NOT KNOWN