BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2161681 · Received July 14, 2011

    Report

    Report Number
    2531779-2011-04937
    Event Type
    Injury
    Date Received
    July 14, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE PUMP HISTORY CONTAINS DATA FROM (B)(4) 2012; THE DATE OF THE COMPLAINT WAS (B)(6) 2011. THE DATA FROM THE TIME OF THE ORIGINAL COMPLAINT IS UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. UPON REVIEW, THE PUMP HISTORY APPEARS TO BE INACCURATE DUE TO TIME AND DATE CHANGES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. 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. 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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT PATIENT EXPERIENCED BLOOD GLUCOSE (BG) IN THE 40'S MG/DL WITH IRRITATION. THE PATIENT REPORTEDLY WAS TREATED WITH ORANGE JUICE. THE PATIENT REPORTEDLY RESUMED THE PUMP AFTER THE PATIENT WAS ABLE TO KEEP HER BG UP. THE FAMILY MEMBER REPORTED THAT THE PATIENT HAS NO CHANGE IN DIET OR CARBOHYDRATE COUNTING. THE FAMILY MEMBER REPORTED THAT THEY HAVE BEEN CHANGING THE BASAL RATES TO TRY AND ACCOMMODATE THE LOW BG. AT THE TIME OF THE CALL THE PUMP WAS NOT AVAILABLE FOR REVIEW. ON THE FOLLOW-UP CALL, THE PUMP WAS REVIEWED WITH CUSTOMER SUPPORT. IT WAS DETERMINED THAT THE PUMP WAS SET TO AM INSTEAD OF PM SO THE PATIENT HAD BEEN GETTING HER DAY TIME BASAL RATE DURING THE NIGHT AND NIGHT TIME RATES DURING THE DAY. THE PATIENT STATED THAT SHE HAS MULTIPLE BASAL RATES AND THE FAMILY MEMBER RECENTLY ADJUSTED THEM WHICH FURTHER CAUSED ERRATIC BGS BECAUSE OF INCORRECT TIME OF DAY. CUSTOMER SUPPORT INSTRUCTED CORRECTING TIME SETTINGS. THE PATIENT CONTINUES TO USE THE PUMP WITH NO FURTHER REPORTED INCIDENTS. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S HYPOGLYCEMIC EVENT WHILE ON 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 20 YR Required Intervention