BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2861493 · Received November 28, 2012

    Report

    Report Number
    2183996-2012-01822
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT REPORTED THAT SHE HAD ELEVATED BLOOD GLUCOSE LEVELS AS HIGH AS 600 MG/DL FROM (B)(6) 2012 TO (B)(6) 2012 AND WAS NOT ABLE TO LOWER THE LEVELS UNTIL SWITCHING HER BACKUP INFUSION DEVICE. HER TARGET BLOOD GLUCOSE LEVEL IS 120 MG/DL. DURING THE THREE DAYS HER BLOOD GLUCOSE LEVELS WERE ELEVATED SHE CHANGED THE INSULIN CARTRIDGE AND INFUSION SET, BUT HER LEVELS STILL REMAINED ELEVATED. SHE STATED THAT AFTER SWITCHING TO HER BACKUP DEVICE HER BLOOD GLUCOSE LEVELS WENT DOWN "RIGHT AWAY." TROUBLESHOOTING WITH THE PATIENT REVEALED THAT SHE HAD NEVER CHANGED THE ADAPTER ON THE INFUSION DEVICE AND SHE HAD NOTICED AN AIR BUBBLE IN THE INSULIN CARTRIDGE THAT SHE DID NOT PRIME OUT. THE DEVICE HAS NOT DISPLAYED ANY ERROR OF ALERT MESSAGES. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OF SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REPLACED. THE INFUSION DEVICE, ADAPTER, AND INSULIN CARTRIDGE WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES