BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2823275 · Received November 7, 2012

    Report

    Report Number
    2531779-2012-13252
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. 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. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THERE WAS NO ACTIVITY OUTSIDE NORMAL PATIENT USE. A REVIEW OF THE BLACK BOX AND BOLUS HISTORY REVEALED THE FOLLOWING BOLUSES DELIVERED ON (B)(6) 2012: 27 UNITS AT 9:02PM, 25 UNITS DELIVERED AT 2:46PM AND 27 UNITS DELIVERED AT 10:17AM. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO BE WITHIN SPECIFICATION. THE PUMP WAS FOUND TO SUCCESSFULLY PAIR WITH THE TEST METER. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS NOTED. A "NORMAL, EZ-CARB, EZ-BG, AND COMBO" BOLUSES WAS PERFORMED AND ACCURATELY RECORDED IN PUMP HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT MOISTURE WAS FOUND INSIDE THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS TO REPORT THAT ON (B)(6) 2012 AT 9:30 PM THE PATIENT OBTAINED THE BLOOD GLUCOSE LEVEL OF 50 MG/DL, AND SHE EXPERIENCED THE SYMPTOMS OF DIZZINESS, FEELING FAINT AND LETHARGY. THE PATIENT NOTED SHE HAD NOT EATEN DINNER, OR TAKEN ANY BOLUS DOSES OF INSULIN, PRIOR TO THE ONSET OF SYMPTOMS. THE PATIENT DISCONNECTED HERSELF FROM THE PUMP, AND ADMINISTERED SELF-TREATMENT WITH A GLUCAGON INJECTION. THE PATIENT WAS UNABLE TO PROVIDE ANY FURTHER BLOOD GLUCOSE READINGS OBTAINED AFTER THE GLUCAGON TREATMENT. ON (B)(6) 2012 AT 9:45 AM, AFTER MORE THAN TWELVE HOURS WITHOUT INSULIN, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 101 MG/DL. DURING THE TELEPHONE CALL WITH CUSTOMER SUPPORT, THE PATIENT EXPERIENCED THE SYMPTOMS OF CONFUSION, SLOW AND SLURRED SPEECH, NO SPEECH, AND DISTRACTION. THE PATIENT'S PHYSICIAN WAS CONTACTED, WHO ADVISED THE PATIENT TO BE TAKEN TO THE EMERGENCY ROOM. NO INFORMATION WAS PROVIDED ABOUT THE PATIENT'S BLOOD GLUCOSE LEVEL OR TREATMENT IN THE EMERGENCY ROOM. THE PATIENT WAS RETURNED TO INSULIN PUMP THERAPY ON (B)(6) 2012 WITHOUT FURTHER INCIDENTS. THE PATIENT ALLEGEDLY SUFFERED BLOOD GLUCOSE LEVELS AND SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA WHILE USING THE PUMP, AND RECEIVED EMERGENCY MEDICAL ATTENTION. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Life Threatening| R