BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3052086 · Received April 11, 2013

    Report

    Report Number
    2183996-2013-00639
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. (B)(4): NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THE HE HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS FOR THE PAST 2-4 DAYS AND THAT HE DOESN'T THINK HIS INFUSION DEVICE IS DELIVERING THE CORRECT AMOUNT OF INSULIN. HE STATED THAT ON (B)(6) 2013 HIS BLOOD GLUCOSE LEVEL WAS 435 MG/DL AT 11:15PM. THE PATIENT NOTICED AIR BUBBLES IN THE INSULIN CARTRIDGE. HE PRIMED THE DEVICE AND THEN ADMINISTERED A BOLUS OF 6.5 UNITS OF INSULIN. HE DID NOT CONFIRM THAT THE AIR BUBBLES WERE GONE BEFORE BOLUSING. AT 1:00AM ON (B)(6) 2013, HIS BLOOD GLUCOSE LEVEL WAS 416 MG/DL. ALTHOUGH HE DIDN'T SEE ANY AIR BUBBLES, HE PRIMED THE TUBING AND THEN BLOUSED 4 UNITS OF INSULIN. AT 8:00AM HIS BLOOD GLUCOSE LEVEL WAS 249 MG/DL. AT THAT TIME HE HAD DISCONNECTED FROM THE INFUSION DEVICE AND ADMINISTERED 12 UNITS OF INSULIN VIA INJECTION. AT 9:00AM HIS BLOOD GLUCOSE LEVEL WAS 37 MG/DL AND HE ATE YOGURT AND JUICE. AT 11:00AM HIS BLOOD GLUCOSE LEVEL WAS 50 MG/DL AND HE ATE YOGURT, A BANANA, TWO SLICES OF BREAD, AND HE TOOK A 40 MINUTE WALK. AT 1:15PM HIS BLOOD GLUCOSE LEVEL WAS 250 MG/DL AND HE ADMINISTERED AN INJECTION OF 12 UNITS OF INSULIN. AT 6:00PM IT WAS 196 MG/DL AND HE ADMINISTERED 10 UNITS OF INSULIN VIA INJECTION. ON (B)(6) 2013 AT 6:15PM HE CHANGED THE INFUSION DEVICE'S ACCESSORIES. THE PATIENT DID NOT WISH TO CONTINUE TO TROUBLESHOOT AND DISCONTINUED THE CALL. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE, INSULIN CARTRIDGE, AND ADAPTER WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155415 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR UNO MEDICAL INFUSION SET