BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2160996 · Received July 13, 2011

    Report

    Report Number
    2531779-2011-04908
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Report Date
    June 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP REVEALED A CRACKED BATTERY COMPARTMENT AND A STRIPPED BATTERY CAP. THE PUMP WAS UNABLE TO BOOT PROPERLY. A TEST CAP WAS INSERTED FOR TESTING. THE PUMP BOOTED AND WAS TESTED FOR 24 HOURS WITHOUT REBOOTING. THE USER GUIDE INSTRUCTS THE PATIENT TO REPLACE THE BATTERY CAP AT LEAST ONCE PER YEAR AND THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE MISCOLORED. ALSO UNRELATED, 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. ALSO UNRELATED, THE KEYPAD WAS FOUND TO BE PEELING AND TORN AND THE BUTTONS WERE INTERMITTENT/UNRESPONSIVE. A DAMAGED KEYPAD WILL ALLOW CONTAMINATION TO PERMEATE THE BUTTON CONTACTS NEGATIVELY IMPACTING THE BUTTON FUNCTION. THE DAMAGED KEYPAD IS OBVIOUS AND DETECTABLE AND SHOULD ALERT THE USER TO DISCONTINUE USE OF THE PUMP.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THE ANIMAS PUMP WILL NOT POWER ON. REPORTEDLY, THE ANIMAS DID NOT GIVE ANY ALARM OR WARNING PRIOR TO THE POWER OUTAGE. THERE WAS NO EVIDENCE OF PRODUCT MISUSED. THE BATTERY WAS REPORTEDLY REPLACED BUT THE ISSUE WAS NOT RESOLVED. THE ANIMAS REPRESENTATIVE ADVISED THE PATIENT TO TRY A BRAND NEW BATTERY AND TO CONTACT ANIMAS BACK IF THE ISSUE IS NOT RESOLVED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE ALLEGED ISSUE. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED POWER ISSUE WITH THE ANIMAS PUMP.

    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 51 YR