BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2192071 · Received August 4, 2011

    Report

    Report Number
    2531779-2011-05619
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    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: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT THE TIME AND DATE DEFAULTED SOMETIME AFTER (B)(6) 2011. THE LAST RECORDED DATE IN THE HISTORY IS (B)(6) 2007, INDICATING THAT THE PATIENT DID NOT CORRECT THE TIME AND DATE AFTER THE PUMP DEFAULTED TO (B)(6) 2007 AND THE PUMP WAS RUNNING FOR ABOUT TWO MONTHS WITH THE INCORRECT TIME AND DATE. 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. INVESTIGATION COULD NOT CONFIRM OR DUPLICATE THE ALLEGATION THAT THE TIME WAS RANDOMLY CHANGING TO (B)(6) 2008 AND THAT THE AUTO-OFF ALARM DID NOT RECORD IN THE HISTORY. A REVIEW OF THE PUMP HISTORY SHOWED MULTIPLE AUTO-OFF ALARMS.

    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.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT THE DATE AND TIME ON THE ANIMAS IS NOT ACCURATELY KEPT IN THE SYSTEM. ACCORDING TO THE PATIENT, DESPITE HIS REPEATED ATTEMPTS TO CORRECTLY ADJUST HIS TIME AND DATE ACCORDINGLY, THE PUMP DEFAULTS TO (B)(6) 2008 ON SOME OCCASION AND (B)(6) 2008 AT OTHER TIMES. IT IS NOT KNOWN IF THE SUBJECT PUMP REBOOTED AND PROMPTED FOR THE VERIFY DATE AND TIME SCREEN AFTER THE TIME CHANGE. IN ADDITION, THE AUTO-OFF ALARM WAS NEVER RECORDED IN THE HISTORY RECORD OF THE ANIMAS PUMP WHEN IT OCCURRED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED INACCURATE HISTORY RECORD OF AUTO-OFF ALARM AS WELL AS A DATE AND TIME ISSUE.

    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 39 YR