BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2221990 · Received August 24, 2011

    Report

    Report Number
    2531779-2011-06185
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX AND PUMP HISTORY REVEALED NO ACTIVITY OUTSIDE NORMAL USE. THERE WAS NO DATA AVAILABLE FROM THE TIME OF THE ALLEGED EVENT DUE TO CONTINUED PATIENT USE; THE DATA WAS OVERWRITTEN. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    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

    THE PATIENT REPORTEDLY EXPERIENCED A BLOOD GLUCOSE (BG) GREATER THAN 500 MG/DL. A FAMILY MEMBER REPORTED THAT THIS OCCURRED AFTER DOING THE FIRST SITE INSERTION WITHOUT SUPERVISION. THE PATIENT'S BG REPORTEDLY ELEVATED ON (B)(6) 2011 TO 200 MG/DL AND CONTINUED TO INCREASE TO OVER 500 MG/DL WITHOUT SYMPTOMS. IT WAS REPORTED THAT THE SITE WAS CHANGED AND A CORRECTION BOLUS WAS DELIVERED USING THE PUMP; THE PATIENT'S BG DECREASED TO 328 MG/DL. DURING THE CALL THE FAMILY MEMBER MENTIONED THAT THE PUMP EMITTED AN "EXCEEDS MAX TDD" WARNING AND CUSTOMER SUPPORT WALKED THE FAMILY MEMBER THROUGH INCREASING THIS LIMIT FOR TREATMENT; THIS WARNING INDICATED THAT THE PUMP SAFETY FEATURE WORKED APPROPRIATELY AND ALARMED TO ALERT THE USER OF THE ISSUE. (B)(4) INSTRUCTED THE FAMILY MEMBER TO CHANGE THE SITE WITH BG ELEVATIONS AND ON SITE CHANGE INSTRUCTIONS. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT 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 5 YR Life Threatening| R