BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2971393 · Received February 21, 2013

    Report

    Report Number
    2531779-2013-01970
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    FOLLOW-UP #1 (B)(4) DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THERE WAS NO ACTIVITY RELATED TO THE REPORTED COMPLAINT OBSERVED IN THE BLACK BOX HISTORY. A REVIEW OF THE BOLUS HISTORY REVEALED THAT THE DATES CHANGED FROM (B)(6) 2012 TO (B)(6) 2013 AND THEN FROM (B)(6) 2013 TO (B)(6) 2012. NO DATA IN THE BLACK BOX WAS INDICATED FROM DATES NOTED ABOVE DUE TO CONTINUED PATIENT USE. DURING TESTING, A TIMEKEEPING ACCURACY TEST WAS PERFORMED; THE PUMP WAS FOUND TO ACCURATELY KEEP TIME. THE BATTERY WAS REMOVED AND THE PUMP WAS LEFT WITHOUT POWER FOR 23 HOURS; WHEN THE PUMP WAS POWERED ON, THE TIME AND DATE DEFAULTED TO FACTORY SETTINGS. UNRELATED TO THE COMPLAINT, AN INTERNAL BATTERY FAILURE WAS OBSERVED DURING INVESTIGATION; 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 AND ALLEGED THE FOLLOWING: WHEN THE PHYSICIAN DOWNLOADED PUMP AT VISIT TODAY, THERE WAS A TIME PERIOD FROM (B)(6) 2012 THAT YEAR WAS CHANGED TO SHOW 2013. THE REPORTER IS UNAWARE OF HOW DATE WAS CHANGED, AND STATES THE PUMP MAINTAINS CORRECT TIME AND DATE WITH BATTERY CHANGES. THE PHYSICIAN ADVISED PATIENT TO CALL ANIMAS TO HAVE DATA CLEARED SO SHE WILL HAVE ACCURATE DATA MOVING FORWARD. PATIENT IS PREGNANT AND THEY ARE MONITORING HER VERY CLOSELY. CUSTOMER TECHNICAL SUPPORT (CTS) INFORMED THE PATIENT THAT WE ARE NOT ABLE TO CLEAR THE DATE AND WILL REPLACE PUMP, AND EDUCATED PATIENT ON BEING CAREFUL WHEN VERIFYING TIME/DATE ON VERIFY SCREEN. THERE IS NO INDICATION OF A BLOOD GLUCOSE EXCURSION RELATED TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED AS IT WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77035 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR