BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2173036 · Received July 23, 2011

    Report

    Report Number
    2531779-2011-05137
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #2 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN NO DEFECT WAS FOUND. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. REVIEW OF THE AVAILABLE BLACK BOX AND ALARM HISTORY SHOW NO ERRORS OR ALARMS RELATED TO THE COMPLAINT. THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO CORRECTLY REFLECT THE USER'S PROGRAMMED BASAL RATES. THE BLACK BOX CONTAINS DATES FROM (B)(4) 2013. DUE TO CONTINUOUS USED OF THE PUMP THE BLACK BOX DATA AND HISTORIES FOR THE EVENT ON (B)(4) 2011 HAVE BEEN OVERWRITTEN. 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

    (B)(6). 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

    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.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT ON (B)(6) 2011 THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM (ER) WITH A BLOOD GLUCOSE (BG) OF 471 MG/DL AND POSITIVE KETONES. SHE STATED THAT THE PATIENT'S BG HAD BEEN ELEVATED EARLIER IN THE DAY AFTER A ROUTINE SITE/SET CHANGE, AND THE PATIENT'S BG CONTINUED TO RISE DESPITE DELIVERY OF CORRECTION BOLUSES. THE FAMILY MEMBER WAS UNABLE TO TROUBLE SHOOT THE PUMP AT THE TIME OF THE CALL. A REVIEW OF THE INFUSION SET INSERTION INDICATED THAT INSERTION TECHNIQUE MAY BE INCORRECT. NO FURTHER INFORMATION WAS PROVIDED. THE PUMP IS NOT BEING RETURNED AT THIS TIME, AND THERE HAS BEEN NO FURTHER REPORTED INCIDENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA 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 12 YR Required Intervention