BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2221576 · Received August 18, 2011

    Report

    Report Number
    2183996-2011-02294
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, COMPANY REPRESENTATIVE REPORTED PATIENT REPORTED EXPERIENCING A LOW BLOOD GLUCOSE EVENT WHILE USING THE INFUSION DEVICE. COMPANY REPRESENTATIVE STATED PATIENT REPORTED ONE DAY LAST WEEK HE WAS WORKING AND PASSED OUT AND THE CUSTOMER HE WAS WITH CALLED THE EMS WHO CAME AND TOOK HIS BLOOD GLUCOSE LEVEL ON THEIR METER AND GOT 27 MG/DL. PATIENT STATED HE WAS ABLE TO TALK TO EMS AND THEY GAVE HIM A GLUCAGON SHOT AND RIGHT AWAY HE FELT BETTER. PATIENT REPORTED HE THEN ATE PEANUT BUTTER CRACKERS AND WAS FEELING FINE. PATIENT WAS NOT TAKEN TO THE HOSPITAL AND CONTINUED HIS WORK DAY. PATIENT STATED HE LAST CHECKED HIS BLOOD GLUCOSE LEVEL ABOUT 3 HOURS PRIOR AND THINKS THE READING WAS 141 MG/DL. PATIENT REPORTED IT WAS A NORMAL DAY FOR HIM AND THERE WAS NOTHING OUT OF THE NORMAL WITH MEDICATION, LIFESTYLE OR DIET. PATIENT STATED HE LAST ATE 3 HOURS PRIOR AND LAST DELIVERED A BOLUS OF 6.0 UNITS OF INSULIN. PATIENT REPORTED THE INCIDENT WAS NO FAULT OF THE METER OR INFUSION DEVICE; STATED HE JUST CAN'T DETECT LOW BLOOD GLUCOSE LEVELS. ADVISED THE COMPANY REPRESENTATIVE THE PATIENT WOULD RECEIVE A FOLLOW UP REGARDING THE INCIDENT. ON FOLLOW UP CALL, PATIENT REPORTED THERE WERE NO ISSUES WITH THE INFUSION DEVICE. PATIENT STATED IT WAS HIS OWN FAULT HIS BLOOD GLUCOSE LEVEL DROPPED LOW. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL IS USUALLY AROUND 100 MG/DL. PATIENT REPORTED AFTER RECEIVING TREATMENT, HIS BLOOD GLUCOSE LEVEL REMAINED NORMAL. PATIENT STATED HE DID NOT HAVE ANY ISSUES WITH THE INFUSION SETS EITHER. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R INSULIN INFUSION SET| INSULIN