BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2230537 · Received September 1, 2011

    Report

    Report Number
    2531779-2011-06414
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS OBSERVED TO BE TORN AT THE UP ARROW BUTTON. A DAMAGED KEYPAD WILL PERMIT CONTAMINATION TO PERMEATE THE BUTTONS WHICH WILL HAVE A NEGATIVE IMPACT ON BUTTON FUNCTION. THE DAMAGED KEYPAD SHOULD BE CLEARLY VISIBLE AND WARNS THE PATIENT TO DISCONTINUE USING THE PUMP. THE KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, THE BOLUS...

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT AFTER THE PATIENT WENT SWIMMING, THE PUMP BEGAN TO BEEP AND THE PATIENT SAW THAT THE PUMP WAS TRYING TO DELIVER A 10 UNIT AUDIO BOLUS. THE PATIENT WAS REPORTEDLY ABLE TO CANCEL THE BOLUS AT 2.0 OF 10 UNITS. THE FAMILY MEMBER REPORTED THAT THE PUMP WAS IN HIS POCKET AT THE TIME OF THE EVENT AND THE PATIENT WAS NOT PRESSING THE BUTTONS. THE PATIENT REPORTEDLY FOUND THE PUMP ATTEMPTING TO DELIVER A 1 UNIT BOLUS WHICH WAS CANCELLED AT 0 OF 1 UNIT. THE PATIENT REPORTEDLY DISCONNECTED FROM THE PUMP. THE PUMP REPORTEDLY CONTINUED TO GIVE AUDIO BOLUSES OF DIFFERENT AMOUNTS. THE PATIENT REPORTEDLY DID NOT EXPERIENCE A BLOOD GLUCOSE EXCURSION BECAUSE THE PATIENT ATE A SMALL SNACK. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PUMP DELIVERED AN UNPROGRAMMED AUDIO BOLUS.

    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 11 YR