BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2193053 · Received August 5, 2011

    Report

    Report Number
    2531779-2011-05637
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. ACCORDING TO THE PUMP HISTORY, A LOW BATTERY WARNING WAS CONFIRMED ON (B)(6) 2011 AT 1:08 AM; A REPLACE BATTERY ALARM WAS OBSERVED ON (B)(6) 2011 AT 8:44 AM, THE BATTERY WAS CHANGED AT 11:45AM. THE PUMP ELECTRICAL CURRENT DRAWS WERE TESTED AND WERE FOUND TO BE WITHIN SPECIFICATIONS. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. UNRELATED TO THIS COMPLAINT, THE KEYPAD LETTERING WAS FOUND TO BE WORN; THIS ISSUE HAS NO EFFECT ON THE PUMP'S INSULIN DELIVERY FUNCTION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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. (B)(6).

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 541MG/DL WITH NO SYMPTOMS. THE PATIENT WAS REPORTEDLY TREATED WITH A BOLUS FOR THE ELEVATION. THE FAMILY MEMBER FELT THAT ELEVATION WAS IN PART DUE TO EATING AND HAVING A COLD. THE FAMILY MEMBER REPORTED THAT THERE WAS DRIED BLOOD AT THE PATIENT'S SITE, INSERTED (B)(6). THE FAMILY MEMBER REVIEWED THE BOLUS HISTORY AND FOUND THAT ALL BOLUSES WERE DELIVERED AND ADD UP WITH TOTAL DAILY DOSE. THE PUMP TIME AND DATE WERE CORRECT. THE FAMILY MEMBER DECLINED TO FURTHER REVIEW PUMP AS SHE DID NOT FEEL THERE WAS ANYTHING WRONG WITH THE PUMP. THE FAMILY MEMBER REPORTED THAT THE PATIENT WOKE TO THE PUMP POWERED OFF; SHE REPORTED THAT SHE CHANGED THE BATTERY AND PUMP POWERED ON. THE PUMP HISTORY REPORTEDLY SHOWED A REPLACE BATTERY ALARM PRIOR TO THE PUMP POWERING OFF. THE PATIENT'S BG ON WAKING WAS 451MG/DL WITH NO SYMPTOMS. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCE HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention