BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2934807 · Received January 30, 2013

    Report

    Report Number
    2531779-2013-01337
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    January 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 03/15/2013- DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED POWER ON RESETS. THE BATTERY COMPARTMENT WAS CRACKED AT THE THREADS. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP. THE BATTERY CAP WAS STRIPPED AT THE THREADS AND COULD NOT BE FULLY TIGHTENED WHICH DUPLICATED THE INTERMITTENT POWER ISSUE. A NEW TEST CAP WAS ATTACHED AND THE PUMP WAS EXERCISED FOR 24 HOURS AND NO POWER ISSUES OCCURRED. THE PUMP COVER WAS REMOVED AND NO INTERNAL MOISTURE OR DAMAGE WAS FOUND TO THE POWER CIRCUIT. UNRELATED TO THE COMPLAINT, THE HISTORY SHOWED THE TIME AND DATE RESET TO FACTORY SETTINGS AFTER THE POWER ON RESETS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE PUMP ALLEGEDLY LOST POWER DURING THE REWIND STEP WITH MULTIPLE BATTERIES. 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
    40385 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR