BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2232040 · Received September 1, 2011

    Report

    Report Number
    2531779-2011-06424
    Event Type
    Injury
    Date Received
    September 1, 2011
    Report Date
    August 5, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    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. 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

    THE PATIENT CLAIMED THAT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2011 WITH ELEVATED BLOOD GLUCOSE OF 300-450 MG/DL AROUND THE SAME TIME SHE RECEIVED HER ANIMAS REPLACEMENT PUMP. THE PATIENT DID NOT HAVE ANY SYMPTOMS TO SUGGEST ACUTE COMPLICATION OF DIABETES AT THE TIME OF CONCERN. THE PATIENT WAS TREATED WITH IV DRIP DURING HER HOSPITAL STAY. THE PATIENT CALLED FOR ASSISTANCE WITH HER ANIMAS PUMP. SHE RECEIVED THE REPLACEMENT PUMP AND WANTED TO MAKE SURE SHE IS PROGRAMMING THE PUMP CORRECTLY. THE ANIMAS REPRESENTATIVE WAS ABLE TO WALK THE PATIENT THROUGH ADJUSTING THE ANIMAS PUMP ACCORDINGLY. THE ISSUE WAS RESOLVED. THE ANIMAS REPRESENTATIVE CONCLUDED THERE WAS NO PUMP MALFUNCTION ASSOCIATED WITH THE ALLEGED EVENT. THIS COMPLAINT IS BEING REPORTED DUE POSSIBLE USER ERROR AND BECAUSE THE PATIENT RECEIVED TREATMENT SUGGESTIVE FOR HYPERGLYCEMIA WHILE SHE MANAGED HER DIABETES WITH THE ANIMAS 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 19 YR Hospitalization| R