BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2250010 · Received September 15, 2011

    Report

    Report Number
    2531779-2011-06843
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 21, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO ALARMS RELATED TO THE COMPLAINT IN THE ALARM HISTORY. A REVIEW OF THE TOTAL DAILY DOSE BASAL DELIVERY SHOWED THAT THE PUMP WAS DELIVERING ACCURATELY AND CORRECTLY REFLECTED THE USER'S ACTIVE BASAL PROGRAM. TYPICAL USAGE ALARMS AND WARNINGS WERE OBSERVED IN THE BLACK BOX DOWNLOAD. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 10/31/2011-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD BUTTONS WERE FOUND TO BE UNRESPONSIVE TO PRESSES. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACTS.

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT ON (B)(6) 2011 THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) OF 25 MMOL/L AND HIS CHEST "FEELS HEAVY" AFTER THE KEYPAD BUTTONS BECAME UNRESPONSIVE. THE FAMILY MEMBER REPORTED THAT THE PATIENT REBOOTED THE PUMP TO CLEAR AN ALARM, AND THE KEYPAD BUTTONS BECAME UNRESPONSIVE AFTER THE PUMP WAS REBOOTED. THE FAMILY MEMBER STATED THAT THE PATIENT WEARS THE PUMP IN HIS POCKET AND DOES NOT CLEAN THE PUMP. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT AFTER THE KEYPAD BUTTONS BECAME UNRESPONSIVE.

    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 13 YR