BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2141642 · Received June 27, 2011

    Report

    Report Number
    2531779-2011-04502
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Report Date
    May 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2011-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE WORN BUT INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD ADHESIVE 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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/REPORTER CONTACTED ANIMAS ON BEHALF OF HIS SON (THE PATIENT) ALLEGING THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE PATIENT CLAIMED THAT THE PUMP WAS INTERMITTENTLY NOT RESPONDING TO BUTTON PRESSES. THE REPORTER DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE.

    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 6 YR