BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3212290 · Received July 9, 2013

    Report

    Report Number
    2183996-2013-01225
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 24, 2013
    Report Date
    August 1, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE S/N IS NOT AVAILABLE, THE COMPLAINT COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN WHAT THE SERIAL NUMBER OF THE DEVICE IS AS THE INITIAL REPORTER COULD NOT SEE TO READ IT. IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. DEVICE WAS NOT REQUESTED TO BE RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REQUESTED ASSISTANCE PROGRAMMING A SECOND BASAL PROFILE ON THE INFUSION DEVICE. PATIENT STATED SHE HAS BEEN EXERCISING MORE AND IT HAS CAUSED HER TO HAVE SOME LOW BLOOD GLUCOSE LEVELS. PATIENT REPORTED HER BLOOD GLUCOSE LEVEL WAS DOWN TO 35 MG/DL AFTER EXERCISING THIS MORNING AND SHE FELT VERY CONFUSED AND WEAK. PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 80-120 MG/DL. PATIENT STATED HER HUSBAND GAVE HER TOAST AND JELLY. PATIENT REPORTED SHE WAS ABLE TO EAT IT ON HER OWN BUT WOULD NOT HAVE BEEN ABLE TO RETRIEVE THE FOOD ON HER OWN. PATIENT STATED THERE ARE NO ISSUES WITH THE INFUSION DEVICE AND HER RECENT SURGE IN EXERCISING IS THE CAUSE OF HER LOW BLOOD GLUCOSE LEVELS. PATIENT REPORTED THE RUBBER ON THE UP AND DOWN ARROW BUTTONS ON THE INFUSION DEVICE IS PEELING AWAY. PATIENT STATED THE BUTTONS STILL WORK FINE. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314189 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 052 YR Required Intervention ASPIRIN| ZOCOR| ACCUPRIL| ESTROGEN| PROGESTERONE| FISH OIL| HUMALOG| SONATA