BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242992 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11747
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED FOR RETURN. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS FOR ASSISTANCE IN INSERTING A NEW SITE AND RESUMING THE PUMP, AND NOTED THAT SHE HAD BEEN OFF THE PUMP DUE TO A LOW BLOOD GLUCOSE (BG) EPISODE THE PREVIOUS DAY. THE PATIENT STATED THAT ON (B)(6) 2013 AROUND 9:00AM SHE CHANGED HER SITE AND FILLED A NEW CARTRIDGE, AND RAN OUT BY THAT AFTERNOON. A FAMILY MEMBER REPORTEDLY FOUND HER PASSED OUT ON THE FLOOR AND EMT WAS CONTACTED. THE PATIENT¿S BG WAS REPORTEDLY AROUND 20MG/DL AND SHE WAS TREATED WITH IV DEXTROSE. THE PATIENT STATED SHE WAS NOT TRANSPORTED TO THE HOSPITAL. THE PATIENT HAD REPORTEDLY FALLEN DUE TO THE LOW BG AND BROKE TWO TOES. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE PUMP WITH THE PATIENT AND FOUND SEVERAL PRIMES AND FILL CANNULA STEPS HAD BEEN PERFORMED ON (B)(6) 2013. THERE WAS ALSO A LARGE PRIME VOLUME OF 104.9 UNITS. THE PATIENT DENIED PRIMING WHILE ATTACHED, BUT COULD NOT REMEMBER THE DETAILS OF THE INCIDENT WELL. THE PATIENT STATED THAT AT 8:39AM HER BG WAS 261MG/DL AND SHE ATE 48GRAMS OF CARBOHYDRATES FOR BREAKFAST AND GAVE A 3.1UNIT BOLUS FOR THE CARBS AND BG. THE HISTORY SHOWS TWO 0.0 UNIT BOLUSES AT 9:17AM AND 9:20AM AND THE PATIENT STATED THAT WAS THE TIME SHE WAS TRYING TO CHANGE THE SITE. THE PATIENT REPORTEDLY REMAINED OFF THE PUMP UNTIL THE MORNING OF (B)(6) 2013 AND HER BG WAS 547MG/DL WITH NO SIGNS OR SYMPTOMS. IT IS UNCLEAR IF THE PATIENT WAS ON INJECTIONS WHILE SHE WAS OFF THE PUMP OR NOT. CTS WALKED THE PATIENT THROUGH CHANGING THE INSET AND REWIND AND PRIME STEPS, AND WALKED HER THROUGH GIVING A BOLUS FOR ELEVATED BG. A REVIEW OF THE PUMP INDICATED ALL SETTINGS AND HISTORIES WERE CORRECT. THE PATIENT DECLINED TO REVIEW ANY FURTHER. THE PATIENT STATED SHE THINKS SHE MADE A MISTAKE, BUT DID NOT BELIEVE SHE PRIMED WHILE ATTACHED. THERE WAS NO PUMP DEFECT FOUND ON TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA WHILE USING INSULIN PUMP THERAPY AND SUBSEQUENT HYPERGLYCEMIA WHILE USING A POTENTIALLY INADEQUATE BACKUP PLAN. USE ERROR CANNOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR IN THE REPORTED INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343004 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R