BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1551372 · Received November 30, 2009

    Report

    Report Number
    2183996-2009-02772
    Event Type
    Injury
    Date Received
    November 30, 2009
    Date of Event
    October 30, 2009
    Report Date
    November 2, 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
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2009, PT REPORTED 3 DAYS AGO, SHE NOTICED HER READINGS WERE HIGHER THAN NORMAL. SHE STATED THEY WERE RANGING BETWEEN 251 - 295 MG/DL. PT'S NORMAL BLOOD GLUCOSE RANGE IS BETWEEN 130 - 180 MG/DL. SHE STATED SHE KEPT BOLUSING TO HELP BRING THEM DOWN BUT THEY STILL REMAINED ELEVATED. PT REPORTED SHE THEN INSPECTED HER INFUSION TUBING AND FOUND AN AIR BUBBLE RIGHT AT THE LUER LOCK CONNECTION WHERE THE TUBING MEETS THE LUER LOCK. SHE SAID SHE TRIES TO PRIME IT BUT IT WON'T COME OUT. SHE STATED SHE DOES NOT ALLOW THE INSULIN TO REACH ROOM TEMPERATURE AND USES IT RIGHT OUT OF THE REFRIGERATOR. ADVISED SHE LEAVES IT OUT FOR ABOUT 45 MINUTES. PT REPORTED THE INFUSION DEVICE HAS NOT GIVEN ANY ERROR MESSAGES TO INDICATE A MALFUNCTION. HAD HER TRY TO PRIME THE AIR BUBBLE OUT OF THE TUBING NOW BUT THE AIR BUBBLE WOULD NOT PRIME OUT. SHE THEN CHANGED HER TUBING AND PRIMED SUCCESSFULLY WITHOUT ANY AIR BUBBLES. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION SETS AND ADAPTER WAS REPLACED AND REQUESTED RETURN OF ALLEGED INFUSION SET FOR EVALUATION. ON FOLLOW UP CALL TWO DAYS LATER, PT REPORTED SHE TRIED THE NEW INFUSION SETS AND ADAPTER BUT THE AIR BUBBLES STILL RETURN. SHE STATED SHE HAD SOME IN THE NEW TUBING TODAY ALSO. PT REPORTED SHE HAS ALSO TRIED THE CARTRIDGE WITH ROOM TEMPERATURE INSULIN AND THE AIR BUBBLES HAVE STILL OCCURRED. SHE STATED SHE HAS A BACKUP INFUSION DEVICE. ASKED HER TO TRY THE BACKUP INFUSION DEVICE AND SEE IF IT HELPED WITH THE AIR BUBBLES. ASKED HER TO CALL BACK IF THE AIR BUBBLES CONTINUED ON THE BACKUP. ON CALL BACK TWO DAYS LATER, PT REPORTED SHE TRIED HER BACKUP INFUSION DEVICE AND HER READINGS HAVE RETURNED TO NORMAL. INFUSION DEVICE WAS REPLACED AND REQUESTED RETURN OF PRIMARY INFUSION DEVICE 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 66 YR Required Intervention INSULIN INFUSION SET| INSULIN