BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2080743 · Received May 6, 2011

    Report

    Report Number
    2531779-2011-03206
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 PUMP TOTAL DAILY DOSE HISTORY FROM (B)(6) 2010 TO END OF PUMP USE ON (B)(6) 2011 REVEALED THAT DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. A 29-HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING INSULIN WITHIN SPECIFICATIONS. DURING INVESTIGATION, A 10 U NORMAL BOLUS WAS PROGRAMMED FROM THE PUMP MENU; PUMP ACCURATELY DELIVERED 10 U AND THE BOLUS WAS CORRECTLY RECORDED IN BOLUS HISTORY WITH CORRECT DATE AND TIME. IOB CORRECTLY RECORDED ON 'STATUS 2' SCREEN. THE PUMP BLACKBOX HISTORY SHOWED NO SIGNS OF THE PUMP RESETTING DATE/TIME TO DEFAULT SETTINGS FROM (B)(6) 2011 - END OF PUMP USE ON (B)(6) 2011. PUMP DID NOT RESET TIME/DATE DURING INVESTIGATION. UNRELATED TO THE COMPLAINT, PEELING PAINT OBSERVED DURING VISUAL INSPECTION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE THE RESULTS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE PROGRAMMED A BOLUS DOSE OF 3.0 UNITS FROM HER PUMP AND HOURS LATER REVIEWED THE PUMP HISTORY AND THE DOSE WAS MISSING. THE PATIENT REPORTED THAT HER BLOOD GLUCOSE LEVEL WAS ELEVATED TO 17.5 MMOL/L AFTER THE 3.0 UNIT BOLUS DOSE WHICH MAKES THE PATIENT BELIEVE SHE DID NOT RECEIVE THE DOSE SHE PROGRAMMED. THERE WERE NO REPORTED SYMPTOMS WITH THE BLOOD GLUCOSE ELEVATION AND NO EVIDENCE OF A SERIOUS INJURY. ALL OTHER DOSES THAT SHE PROGRAMMED REPORTEDLY APPEARED IN THE PUMP HISTORY.

    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 43 YR