BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1033339 · Received April 23, 2008

    Report

    Report Number
    2183996-2008-00581
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 17, 2008
    Report Date
    April 1, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED ELEVATED BLOOD GLUCOSE READINGS OF UP TO 345 MG/DL WITH HER NORMAL RANGE BEING 130-135 MG/DL. SHE STATED HER SYMPTOMS WERE DIZZINESS, WEAKNESS, AND MEMORY LOSS. DURING TROUBLESHOOTING, THE PT STATED SHE CHECKS HER BLOOD SUGARS EVERYDAY AT 8:00 AM, 1:00 PM AND 7:30 PM AND SHE GIVES HERSELF 20 UNITS OF INSULIN AT BREAKFAST, LUNCH AND DINNER REGARDLESS OF WHAT SHE EATS. SHE STATED SHE HAS BEEN USING HER INSULIN INFUSION DEVICE FOR 7 MONTHS AND IT HAS NOT GIVEN ANY ERRORS OR ALERTS. SHE STATED SHE FILLS HER CARTRIDGE WITH INSULIN STORED IN THE REFRIGERATOR. THE PT WAS ADVISED TO ALLOW THE INSULIN TO REACH ROOM TEMPERATURE BEFORE FILLING HER CARTRIDGE. SHE STATED SHE DID NOT THINK HER INFUSION DEVICE WAS PROPERLY WORKING. THE PT WAS ADVISED TO SWITCH TO HER BACKUP DEVICE TO SEE IF HER READINGS IMPROVED. THE PT WAS ASSISTED IN SETTING UP HER BACKUP DEVICE. ON FOLLOW UP, THE PT STATED THAT HER READINGS RETURNED TO HER NORMAL RANGE WHILE USING HER BACKUP INFUSION DEVICE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN INFUSION SET| INSULIN