BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3241429 · Received July 22, 2013

    Report

    Report Number
    2531779-2013-11603
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/19/2013 WITH THE FOLLOWING FINDINGS: THE PUMP HISTORY SHOWS THE LAST BOLUS AND THE LAST BASAL WERE DELIVERED (B)(6) 2013. HISTORY ALSO SHOWS PUMP WAS SUSPENDED (B)(6) 2013 22:17 UNTIL (B)(6) 2013 00:17. THE TOTAL DAILY DOSE THREE DAYS PRIOR TO THE EVENT ADDED UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATE. ONLY TYPICAL USAGE ALARMS AND WARNINGS WERE OBSERVED IN THE ALARM HISTORY; THERE WERE NO ALARMS RELATED TO THE COMPLAINT RECORDED. THE PUMP SUCCESSFULLY PASSED A 29 HOUR FLOW ACCURACY TEST. THE PUMP FOUND TO BE DELIVERING ACCURATELY AND OPERATING WITHIN REQUIRED RANGE. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH DIABETIC KETOACIDOSIS AND WAS TAKEN OFF THE PUMP AND TREATED WITH AN INSULIN DRIP. THERE WERE NO BLOOD GLUCOSE VALUES PROVIDED. THE PATIENT WAS PUT BACK ON THE PUMP FEW HOURS BEFORE THEY WERE DISCHARGED HOME. THE REPORTER STATED THAT THE PATIENT¿S SITE, TUBING CARTRIDGE AND INSULIN WERE ALL CHANGED WHEN SHE WAS PUT BACK ON THE PUMP. THE REPORTER STATED THAT THE BLOOD GLUCOSE WAS IN THE 200MG/DL RANGE SINCE DISCHARGE AND NOW UP TO 400MG/DL WITH NO SYMPTOMS. TROUBLESHOOTING INDICATED THAT THERE WERE NO ASSOCIATED ALARMS IN THE HISTORY, BOLUS HISTORY WAS CORRECT, BASAL SETTINGS AND TOTAL DAILY DOSE BASAL HISTORY MATCH. THE REPORTER STATED THAT THE PATIENT IS GOING THROUGH PUBERTY. CUSTOMER SUPPORT DETERMINED THERE WAS NO ISSUE WITH THE PUMP. THE PUMP IS NOT BEING RETURNED AND THE PATIENT CONTINUES PUMP THERAPY. THIS REPORT IS BEING MADE DUE TO THE ALLEGED HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340239 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR