BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2073480 · Received May 1, 2011

    Report

    Report Number
    2531779-2011-03007
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: EVALUATION FOUND THAT THE PUMP POWERS UP PROPERLY AND THE POWER CIRCUIT DOES NOT DRAW EXCESSIVE CURRENT. THE PUMP WAS EXERCISED FOR 5 HOURS WITH NO EVIDENCE OF OVERHEATING AND NO ALARMS. NO DEFECTS WERE FOUND TO THE POWER FLEX, BATTERY CONNECTIONS, AND INTERNAL COMPONENTS. THERE WERE NO ACTIVITIES IN THE PUMP HISTORY RELATED TO THE OVERHEATING COMPLAINT; THE HISTORY INDICATED THAT THE PUMP WAS IN USE UNTIL (B)(6) 2011, THEREFORE THE PUMP HISTORY FROM THE REPORTED EVENT DATES WAS UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. THE OVERHEATING COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION. A REVIEW OF THE PUMP HISTORY INDICATED THAT THE TIME AND DATE HAD RESET TO DEFAULT FACTORY SETTINGS. 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 BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ALLEGING THAT ON (B)(6) 2011 AND (B)(6) 2011 HE RECEIVED A LOW BATTERY ALARM FOLLOWED BY A REPLACE BATTERY ALARM. WHEN HE REMOVED THE BATTERY EACH TIME IT WAS VERY HOT AND THE PUMP WAS ALSO HOT. THE PATIENT DENIED SUSTAINING ANY BURNS OR INJURY AS A RESULT OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE PATIENT DENIED ANY MOISTURE OR CORROSION IN BATTERY COMPARTMENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    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