BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2771335 · Received October 4, 2012

    Report

    Report Number
    2531779-2012-11758
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 25, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2012 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION THE KEYPAD WAS FOUND TO BE DAMAGED; PEELING WAS OBSERVED AT THE UP ARROW BUTTON AND THE KEYPAD WAS WORN. A DAMAGED KEYPAD WILL ALLOW CONTAMINATION TO PERMEATE THE BUTTON CONTACTS NEGATIVELY IMPACTING THE BUTTON FUNCTION. THE DAMAGED KEYPAD IS OBVIOUS AND DETECTABLE AND SHOULD ALERT THE USER TO DISCONTINUE USE OF THE PUMP. A WORN KEYPAD HAS NO EFFECT ON INSULIN DELIVERY. DURING TESTING, THE UP ARROW KEYPAD BUTTON WAS FOUND TO BE INTERMITTENTLY UNRESPONSIVE; THE DOWN ARROW, OK AND CONTRAST BUTTON RESPONDED APPROPRIATELY. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    ON (B)(6) /2012, THE PATIENT CONTACTED ANIMAS, ALLEGING THE UP ARROW AND OK KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND HAD BECOME INCREASINGLY DIFFICULT TO OPERATE OVER TIME. THE PATIENT DENIED DAMAGE TO THE KEYPAD. THE PATIENT REPORTEDLY WORE THE PUMP IN A CASE ATTACHED TO THE WAIST AND DID NOT CLEAN IT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    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 34 YR