BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2232595 · Received September 2, 2011

    Report

    Report Number
    2531779-2011-06433
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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 MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS. 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)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. THERE WAS NO ACTIVITY OUTSIDE OF NORMAL PATIENT'S USE OBSERVED IN THE PUMP'S HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS ALSO PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THERE WERE NO DELIVERY DEFECTS FOUND WITH THE PUMP DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE AWOKE THE MORNING OF (B)(6) 2011 WITH BLOOD GLUCOSE (BG) OF 330 MG/DL, KETONES, AND NAUSEA. SHE STATED THAT HER BGS BEGAN ELEVATING AFTER A SITE CHANGE THE PREVIOUS EVENING; SHE REPORTED THAT THE SITE WAS PAINFUL BUT SHE CONTINUED TO USE THE SITE. THE PATIENT ADMITTED THAT SHE HAD GONE OUT TO EAT AND MAY NOT HAVE APPROPRIATELY CORRECTED FOR FOOD INTAKE. THE PATIENT STATED THAT SHE CHANGED HER SITE THE MORNING OF THE CALL TO CUSTOMER SUPPORT (CS) AND DID NOT SEE ANY ISSUES WITH THE CANNULA. SHE STATED THAT SHE DID NOT NORMALLY EXPERIENCE SITE ISSUES BUT ADMITTED TO HAVING SCAR TISSUE. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT WHILE USING 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 47 YR