BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2123587 · Received June 14, 2011

    Report

    Report Number
    2531779-2011-04148
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 14, 2011
    Report Date
    May 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 07/26/2011. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WAS NO ACTIVITY OUTSIDE NORMAL USE NOTED IN THE PUMP HISTORY. THE DATA FOR THE TIME OF THE REPORTED INCIDENT IS UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE EXPERIENCED BLOOD GLUCOSE (BG) AS LOW AS 2 MMOL/L WITH OCCASIONAL SYMPTOMS OF WEAKNESS, SHAKINESS, AND CONFUSION. SHE REPORTEDLY TREATED LOW BGS WITH ORAL CARBOHYDRATES. THE PATIENT REPORTED THAT SHE THOUGHT THE LOW BGS WERE DUE TO TAKING A SHOWER AS SHE STATED THAT THIS USUALLY CAUSES HER BG TO DROP. THE PATIENT ALSO REPORTED THAT BASAL RATE WAS RECENTLY ADJUSTED DUE TO LOW BG CAUSED BY DIET CHANGES AND BG HAS SINCE BEEN WITHIN TARGET. THIS REPORT IS BEING MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA 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 25 YR Required Intervention