BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2191812 · Received August 4, 2011

    Report

    Report Number
    2531779-2011-05614
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 9, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 BATTERY THAT WAS RETURNED WITH THE PUMP SHOWS EVIDENCE OF OVERHEATING. EVALUATION FOUND THAT THE PUMP POWERS UP PROPERLY AND THE POWER CIRCUIT DOES NOT DRAW EXCESSIVE CURRENT. THE BATTERY COMPARTMENT AND CAP ARE INTACT WITH NO PHYSICAL DAMAGE FOUND. NO DEFECTS WERE FOUND TO THE POWER FLEX, BATTERY CONNECTIONS, AND INTERNAL COMPONENTS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS AND NO OVERHEATING. THE COMPLAINT OF OVERHEATING COULD NOT BE DUPLICATED ON INVESTIGATION. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT ON THE NIGHT OF (B)(6) 2011, THE PUMP BECAME "REALLY HOT." SHE STATED THAT SHE REMOVED THE BATTERY, AND PUT A NEW BATTERY IN THREE HOURS LATER. SHE STATED THAT SHE USED A BACK-UP PLAN IN THE INTERIM, AND HAS HAD NO ISSUES WITH THE PUMP SINCE RESUMING INSULIN PUMP THERAPY WITH THE NEW BATTERY. THE PATIENT DENIED ANY BURNS OR INJURY DUE TO THE INCIDENT. THE PATIENT DENIED PHYSICAL DAMAGE TO THE BATTERY CAP AND COMPARTMENT, AND STATED THAT THE PUMP WAS NOT EXPOSED TO MOISTURE. SHE CONFIRMED THAT THE BATTERY CAP WAS SECURE TO THE PUMP AT THE TIME OF THE INCIDENT. SHE STATED THAT THE BATTERY CAP HAS NEVER BEEN CHANGED. THE USER'S GUIDE INSTRUCTS THE USER TO CHANGE THE BATTERY CAP EVERY SIX MONTHS.

    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 63 YR