BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1346699 · Received March 17, 2009

    Report

    Report Number
    2183996-2009-00377
    Event Type
    Injury
    Date Received
    March 17, 2009
    Date of Event
    March 9, 2009
    Report Date
    March 9, 2009
    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
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2009, THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF 14-19 MMOL/L (252-342 MG/DL) FOR THE PAST WEEK. HER TARGET BLOOD GLUCOSE RANGE IS 6.5-7.0 MMOL/L (117-126 MG/DL). TODAY, HER BLOOD GLUCOSE ELEVATED TO 26 MMOL/L (468 MG/DL) AND SHE CHANGED HER INFUSION SET. SHE BOLUSED 5 UNITS OF INSULIN AND DRANK 2 GLASSES OF WATER TO LOWER HER BLOOD GLUCOSE. SHE STATED THAT SHE SAW A SMALL AIR BUBBLE AT THE TOP OF THE INSULIN CARTRIDGE AND SHE HAS ONGOING ISSUES WITH AIR BUBBLES. SHE STATED THAT THERE ARE NO AIR BUBBLES IN THE INSULIN CARTRIDGE UPON INSERTION INTO THE INFUSION DEVICE AND THEY DEVELOP "A DAY OR TWO LATER". SHE STATED THAT SHE WEARS THE INFUSION DEVICE INVERTED TO KEEP THE AIR BUBBLES FROM MOVING INTO THE INFUSION TUBING. SHE WAS ADVISED TO ALWAYS PRIME AIR BUBBLES OUT OF THE SYSTEM. SHE STATED THAT SHE DOES ALLOW INSULIN TO REACH ROOM TEMPERATURE PRIOR TO USE. THE PATIENT CALLED BACK ON THE SAME DAY, TO REPORT HER BLOOD GLUCOSE HAD LOWERED TO 20 MMOL/L (360 MG/DL). SHE WAS SENT SAMPLE INFUSION SETS AND AN INFUSION SET INSERTION DEVICE. A REQUEST FOR ADDITIONAL TRAINING WAS SUBMITTED. UPON FOLLOW-UP THE NEXT DAY, THE PATIENT STATED THAT HER BLOOD GLUCOSE WAS STILL ELEVATED. SHE STATED THAT SHE CHANGES HER INSULIN CARTRIDGE AND INFUSION SET EVERY 10 DAYS. SHE WAS ADVISED TO CHANGE THE INSULIN CARTRIDGE AND INFUSION TUBING EVERY 6 DAYS AND THE INFUSION SITE EVERY 3 DAYS. THREE DAYS LATER, THE PATIENT REPORTED THAT LAST NIGHT, HER BLOOD GLUCOSE BEGAN TO ELEVATE AGAIN AND SHE "TOOK A LOT OF INSULIN". THIS MORNING, HER BLOOD GLUCOSE MEASURED 15/16 MMOL/L (270-288 MG/DL) AND SHE STATED "I DO FEEL BETTER". THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention INSULIN INFUSION PUMP| INSULIN INFUSION SET| INSULIN