BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1013642 · Received March 13, 2008

    Report

    Report Number
    2183996-2008-00331
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 27, 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
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF 300 MG/DL THE PREVIOUS NIGHT AND OCCLUSION (E4) ERRORS. IN AN ATTEMPT TO TROUBLESHOOT SHE CHANGED HER INFUSION SET TWICE AND CHANGED HER INSULIN CARTRIDGE. THE FOLLOWING MORNING HER BLOOD GLUCOSE WAS STILL ELEVATED (200 MG/DL) AND SHE BOLUSED AND RECEIVED AN OCCLUSION ERROR. SHE STATED THAT SHE WAS ATTEMPTING TO BOLUS 10-25 UNITS OF INSULIN AND SHE WOULD RECEIVE HALF OF THE BOLUS BEFORE THE INFUSION DEVICE WOULD OCCLUDE. SHE STATED THAT SHE THEN DISCONNECTED FROM HER INFUSION SITE AND PERFORMED A BOLUS AND AGAIN RECEIVED AN OCCLUSION. THE PATIENT WAS ADVISED TO ATTACH AN INFUSION SET FROM A DIFFERENT BOX THAN SHE WAS CURRENTLY USING. SHE ATTACHED A NEW INFUSION TUBING AND INSERTED A NEW INFUSION SITE AND WAS ABLE TO PRIME AND BOLUS WITHOUT ERROR. UPON FOLLOW UP LATER ON THE SAME DAY, THE PATIENT REPORTED HER BLOOD GLUCOSE HAD ELEVATED 100 POINTS SINCE 7:30AM. SHE WAS ADVISED TO SWITCH TO HER BACKUP INFUSION DEVICE. SHE STATED THAT HER ADAPTER HAD NEVER BEEN CHANGED. SHE WAS ADVISED TO CHANGE THE ADAPTER WITH EVERY 10TH CARTRIDGE CHANGE. DURING A FOLLOW UP LATER ON THE SAME DAY, THE PATIENT STATED HER BLOOD GLUCOSE MEASURED 193 MG/DL AT 12:00PM AND THEN LOWERED TO 81 MG/DL. SHE DID NOT SWITCH TO HER BACKUP INFUSION DEVICE. SHE REPORTED THAT SHE HAD BEEN SICK. THE PATIENT CALLED FOR ASSISTANCE ON THE FOLLOWING DAY WITH SETTING UP HER BACKUP INFUSION DEVICE. SHE STATED THAT HER BLOOD GLUCOSE MEASURED 310 MG/DL IN THE MORNING. SHE STATED THAT HER BLOOD GLUCOSE HAS RANGED FROM 16-358 MG/DL SINCE EIGHT DAYS LATER. SHE DRINKS SUGAR WATER OR JUICE TO ELEVATE HER BLOOD GLUCOSE DURING LOWS. ON EIGHT DAYS EARLIER, THE PATIENT REPORTED THAT HER BLOOD GLUCOSE WAS "MUCH BETTER." SHE DECIDED TO SWITCH BACK TO HER PRIMARY INFUSION DEVICE. ON THE FOLLOWING MONTH, THE PATIENT STATED AS SOON AS SHE CONNECTED TO HER PRIMARY INFUSION DEVICE HER BLOOD GLUCOSE BEGAN TO ELEVATE. SHE SWITCHED TO HER BACKUP INFUSION DEVICE AND SHE FELT "WONDERFUL" AND HER BLOOD GLUCOSE HAD RETURNED TO NORMAL. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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