BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2800213 · Received October 22, 2012

    Report

    Report Number
    2531779-2012-12601
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Report Date
    September 25, 2012
    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

    FOLLOW UP #1 SUBMITTED: (B)(4) 2012 DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE PUMP CORRECTLY CALCULATED THE REMAINING INSULIN READING. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT HAS UNEXPLAINED BLOOD GLUCOSE IN THE 200S TO 300S MG/DL AND FELT THAT THE ANIMAS PUMP IS NOT DELIVERING INSULIN PROPERLY. THE PATIENT HAS BEEN OFF OF INSULIN PUMP FOR 2 WEEKS SINCE HIS BLOOD GLUCOSE WAS OUT OF HIS TARGET RANGE. THE PATIENT REQUESTED THAT ANIMAS REPLACED HIS ONETOUCH PING INSULIN PUMP WITH THE 2020 INSULIN PUMP. ANIMAS REPLACED THE SUBJECT PUMP AS REQUESTED. THE ANIMAS PRODUCT WAS REQUESTED BACK FOR INVESTIGATION. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE CONCLUDED THERE WAS NO PUMP MALFUNCTION ASSOCIATED WITH THE ALLEGED EVENT. THERE WERE NO ABNORMALITIES AND NO ALARMS. THE TIME AND DATE WAS PROGRAMMED CORRECTLY AS WELL AS THE BASAL AND ADVANCE FEATURES. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED INACCURATE DELIVERY ISSUE. THE PATIENT'S CONDITION DID NOT MEET ANIMAS CRITERIA OF A SERIOUS INJURY. IN ADDITION, THERE WAS NO REPORT OF ANY HCP MEDICAL INTERVENTION TO SUGGEST A SERIOUS INJURY.

    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 54 YR