BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2102742 · Received May 25, 2011

    Report

    Report Number
    2531779-2011-03686
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 DATE OF SUBMISSION (B)(6) 2011. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP ON (B)(6) 2011 AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2011 WITH A DIAGNOSIS OF DIABETIC KETOACIDOSIS (DKA). SHE STATED THAT THE PATIENT WAS REMOVED FROM THE PUMP AND PLACED ON INTRAVENOUS INSULIN. THE NURSE REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. THE NURSE SAID THAT THE PATIENT DOES NOT THINK THE CANNULA WAS BENT UPON ADMISSION TO THE HOSPITAL. ANIMAS CUSTOMER SUPPORT (CS) REVIEWED THE PUMP HISTORY WITH THE NURSE, AND FOUND THAT ALL SETTINGS WERE CORRECT. THE NURSE STATED THAT THE PATIENT WAS UNABLE TO PROVIDE A REASON FOR THE HYPERGLYCEMIA. THE PUMP IS BEING REPLACED FOR A SHORT BATTERY LIFE COMPLAINT. THIS MALFUNCTION IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE PUMP WILL ALARM TO ALERT THE USER OF THE ISSUE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO BE PREPARED TO GIVE HIS OR HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED DKA WHILE USING THE PUMP.

    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 32 YR Hospitalization