BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2133340 · Received June 20, 2011

    Report

    Report Number
    2531779-2011-04270
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Report Date
    May 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    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 FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT THE CONTRAST AND UP ARROW KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE, AND THE DOWN ARROW KEYPAD BUTTON IS UNRESPONSIVE. THE DOWN ARROW KEYPAD BUTTON DOES NOT HAVE NORMAL SPRING BACK; THE DOWN ARROW BUTTON KEY CONTACT WAS FOUND TO BE INVERTED. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEY CONTACTS. 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 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE DOWN ARROW KEYPAD BUTTON HAS BEEN INTERMITTENTLY UNRESPONSIVE. SHE CONFIRMED THAT THE KEYPAD WAS INTACT. THE PATIENT STATED THAT SHE WORE THE PUMP IN HER POCKET, AND DID NOT EXPOSE THE PUMP TO CLEANING PRODUCTS.

    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 19 YR