BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1275844 · Received December 31, 2008

    Report

    Report Number
    2183996-2008-01988
    Event Type
    Injury
    Date Received
    December 31, 2008
    Date of Event
    December 17, 2008
    Report Date
    December 18, 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 Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN LATE 2008, THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF 14-30 MMOL/L (252-540 MG/DL) AFTER BEGINNING USE OF THE INFUSION DEVICE A DAY PRIOR. HE STATED THAT HIS BLOOD GLUCOSE WAS ELEVATED PRIOR TO BEGINNING USE OF THE INFUSION DEVICE WHILE ON INJECTION THERAPY AS WELL. HE STATED THAT HIS LAST BLOOD GLUCOSE READING MEASURED "HI" ON HIS BLOOD GLUCOSE MONITOR AND HE FELT VERY NERVOUS AND THIRSTY. TO TROUBLESHOOT, THE PATIENT WAS INSTRUCTED TO DISCONNECT FROM HIS INFUSION SITE AND TO BOLUS. HE STATED THAT NO INSULIN DRIPPED FROM THE INFUSION TUBING. HE WAS INSTRUCTED TO PERFORM A PRIME AND AFTER 1.5 PRIME CYCLES A MINIMAL AMOUNT OF INSULIN DRIPPED FROM THE INFUSION TUBING. HE REMOVED THE INSULIN CARTRIDGE AND STATED THAT THERE WAS A LARGE AIR BUBBLE IN IT. HE WAS ASSISTED IN INSERTING A NEW INSULIN CARTRIDGE, AND HE WAS ABLE TO PRIME THE INFUSION TUBING AND RECONNECT TO HIS INFUSION SITE AND BOLUS. THE DAY AFTER THE ORIGINAL DATE, THE PATIENT REPORTED THAT 2 HOURS AFTER THE INITIAL REPORT, AN AIR BUBBLE FORMED IN HIS INSULIN CARTRIDGE. HE CHOSE TO DISCONNECT FROM THE INFUSION DEVICE AND TO USE INJECTION THERAPY. HIS BLOOD GLUCOSE MEASURED 22 MMOL/L (396 MG/DL) AND HE FELT "LOUSY." HE WAS ASSISTED WITH REMOVING THE AIR BUBBLE, AND HE THEN RECEIVED AN E4 (OCCLUSION) ERROR WHILE ATTEMPTING TO PRIME. HE WAS THEN ASSISTED WITH CHANGING THE INSULIN CARTRIDGE. HE RECEIVED ANOTHER E4 WHILE PRIMING THE INFUSION TUBING. HE WAS INSTRUCTED TO ATTACH A NEW INFUSION TUBING AND HE PRIMED WITHOUT ERROR. HE RECONNECTED TO THE INFUSION SITE AND BOLUSED 9 UNITS OF INSULIN. A REQUEST FOR ADDITIONAL TRAINING WAS SUBMITTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET AND INSULIN CARTRIDGE WERE 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 32113358

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R INSULIN| INSULIN INFUSION SET| INSULIN INFUSION PUMP