BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2870779 · Received December 12, 2012

    Report

    Report Number
    2531779-2012-14490
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON (B)(4) 2012, WITH THE FOLLOWING FINDINGS: TESTING WAS UNABLE TO DUPLICATE LARGE PRIME VOLUME. MULTIPLE OCCURRENCES OF HIGH PRIME VOLUME OBSERVED IN HISTORY. FORCE CALIBRATION FAILED WITH A LOW READING. .FORCE SENSOR RESISTANCE TEST FAILED WITH A HIGH READING. DISASSEMBLED FORCE SENSOR, NO EVIDENCE OF SHIM OR PLATE DAMAGE. EVIDENCE OF CONTAMINATION FOUND IN FORCE SENSOR HOUSING AND FORCE SENSOR SHIM. REMOVED PUMP CASE AND NOTED FORCE SENSOR PINS SEATED AND SOLDER CONNECTIONS INTACT. NO EVIDENCE OF MOISTURE CONTAMINATION ON PINS OR IN PUMP.

    Description of Event or Problem · 1

    THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED CONTAMINATION ON FORCE SENSOR, FORCE SENSOR CALIBRATION LOW AND FORCE SENSOR RESISTANCE HIGH. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON (B)(4) 2012.

    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 48 YR