BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3102177 · Received May 9, 2013

    Report

    Report Number
    2531779-2013-06078
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 08/08/2013 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL LAST NIGHT FOR A BLOOD GLUCOSE (BG) OF 36MMOL/L WITH LARGE KETONES AND VOMITING. THE PATIENT WAS TREATED WITH BOLUSES VIA THE PUMP BUT THE BG WAS COMING DOWN VERY SLOWLY SO THE PATIENT WAS TAKEN OFF THE PUMP AND PUT ON IV INSULIN. THE PATIENT'S BG CURRENTLY IS 11MMOL/L. THE REPORTER STATED THAT THE DOCTOR DOES NOT KNOW WHAT THE REASON FOR THE HIGH BG. THEY DO NOT FEEL THAT THERE WERE ANY ISSUES WITH THE PUMP. THE PATIENT'S FAMILY IS NOT BLAMING THE PUMP. THE TROUBLESHOOTING WAS DONE BY DIABETES EDUCATOR IN THE HOSPITAL. THE REPORTER STATED THAT THEY ARE USING METER REMOTE TO CONTROL PUMP. THE REPORTER STATED THAT THE PATIENT WAS PUT BACK ON THE PUMP EARLIER TODAY. ALTHOUGH NO SPECIFIC EVIDENCE OF PUMP MALFUNCTION, DEFECT, OR MISUSE WAS DETECTED, THIS REPORT IS BEING MADE DUE TO THE POSSIBILITY THAT THE USE OF AN INSULIN PUMP MAY HAVE CONTRIBUTED IN AN UNIDENTIFIED MANNER TO THE BLOOD GLUCOSE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203032 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR