BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2071832 · Received April 28, 2011

    Report

    Report Number
    2531779-2011-02954
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO BE WITHIN SPECIFICATION. NO DATA WAS FOUND IN THE BLACK BOX OR DOWNLOAD HISTORY FROM THE TIME OF REPORTED EVENT DUE TO CONTINUED PATIENT USE. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. 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 FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. THE REPORT IS 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 REPORTER, THE PATIENT'S MOTHER, REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2011. THE PATIENT'S DIAGNOSIS WAS A POSSIBLE GASTROINTESTINAL INFECTION. FOR ONE MONTH PRIOR, THE PATIENT EXPERIENCED THE SYMPTOMS OF VOMITING, DIARRHEA AND TESTED POSITIVE FOR KETONES. THE PATIENT OBTAINED ELEVATED BLOOD GLUCOSE READINGS SUCH AS 274 MG/DL, 294 MG/DL AND 303 MG/DL. WHILE HOSPITALIZED, THE PATIENT WAS TREATED INTRAVENOUSLY WITH INSULIN AND FLUIDS. TROUBLESHOOTING REVEALED ALL BASAL/BOLUS DOSES DELIVERED ACCURATELY MATCHED THOSE PROGRAMMED INTO THE PUMP, NO KINKS OR BENDS OR LEAKS IN THE CANNULA, THE PATIENT'S TECHNIQUE WAS CORRECT AND THERE WERE NO ALARMS IN THE PUMP HISTORY. THE PATIENT ALSO REPORTED LUMPS SEEN AT THE INFUSION SITES WHEN THE SITE WAS CHANGED. THERE IS NO EVIDENCE THE PUMP WAS NOT ACCURATELY AND CORRECTLY DELIVERING INSULIN. TROUBLESHOOTING REVEALED THERE MAY HAVE BEEN AN ISSUE WITH THE INFUSION SITES. HOWEVER, AS THE PATIENT EXPERIENCED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WHILE USING THE PUMP, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| L| R