BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2160157 · Received July 13, 2011

    Report

    Report Number
    2531779-2011-04895
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Report Date
    June 15, 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

    AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. 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

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE BATTERY COMPARTMENT. THE BATTERY CAP WAS SECURED AND REBOOTING WAS DUPLICATED. THE BATTERY CAP WAS TESTED AND THE BATTERY CAP CONTACTS WERE FOUND TO BE BENT. A TEST CAP WAS INSERTED. NO ALARMS WERE FOUND IN THE PUMP HISTORY RELATING TO THE COMPLAINT. THE BLACK BOX HISTORY SHOWED SEVERAL REBOOTS HAD OCCURRED. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT THE PUMP REBOOTING. 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.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED POWER ISSUE. THE PATIENT CLAIMED THAT THE ANIMAS PUMP REBOOTS TO THE VERIFICATION SCREEN BUT WILL NOT PROCEED TO THE HOME SCREEN. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE NOTED THE FOLLOWING: THE BATTERY CAP WAS SECURELY ON THE ANIMAS PUMP. THERE WAS NO EVIDENCE OF PRODUCT MISUSED. THERE WAS NO PHYSICAL DAMAGED ON THE BATTERY CAP OR THE BATTERY COMPARTMENT. THE BATTERY WAS REPLACED BUT THE REPORTED ISSUE WAS NOT RESOLVED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    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