BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2132263 · Received June 17, 2011

    Report

    Report Number
    2531779-2011-04242
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP'S DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED ON THE PUMP. PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THE KEYPAD WAS FOUND TO BE TORN AND THE PUMP WAS FOUND TO BE RESETTING TO DEFAULT TIME AND DATE. EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. 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

    A FAMILY MEMBER REPORTED THAT ON THE EVENING OF (B)(6) 2011, THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) OF 500 MG/DL WITH NO SYMPTOMS AND NO KETONES REPORTED. THE FAMILY MEMBER STATED THAT THE INFUSION SET WAS CHANGED AND THE PATIENT'S BG RESOLVED TO AROUND 200 MG/DL. HE STATED THAT THE PATIENT'S MOST RECENT KNOWN BG WAS 163 MG/DL ON THE DAY OF THE CALL TO ANIMAS CUSTOMER SUPPORT (CS). THE FAMILY MEMBER STATED THAT THE PREVIOUS INFUSION SET HAD BEEN IN FOR TWO DAYS; THEY USUALLY CHANGE SETS EVERY THREE DAYS. HE STATED THAT THE CANNULA WAS NOT BENT; THE TUBING WAS NOT KINKED; AND THERE WAS NO LEAKING NOTED AT THE SITE. THE FAMILY MEMBER NOTED THAT THE PATIENT'S SITE AREAS ARE USUALLY IN THE BUTTOCKS OR THE ARMS; HE STATED THERE MAY HAVE BEEN SOME SCAR TISSUE AT THE SITE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED 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 4 YR Required Intervention