BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3960511 · Received July 28, 2014

    Report

    Report Number
    2531779-2014-21560
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/20/2014 WITH THE FOLLOWING FINDINGS: THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP; A TEST CAP WAS USED DURING TESTING. THE PUMP BLACK BOX HISTORY SHOWED THAT THE PUMP EMITTED AN OCCLUSION ALARM RELATED TO HIGH FORCE ON (B)(6) 2014 AT 09:32; THE PUMP DELIVERIES WERE RESUMED AT 10:28. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED AT THE CASE SEAL.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED TO ANIMAS. 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A BLOOD GLUCOSE OF 28 MMOL/L WITH LIGHTHEADEDNESS AND INCREASED THIRST ASSOCIATED WITH AN ALLEGATION OF INACCURATE DELIVERY. THE PUMP WAS REVIEWED WITH THE REPORTER RELATED TO THE COMPLAINT AND CONFIRMED THAT PUMP SETTINGS WERE PROGRAMMED CORRECTLY, THE BASAL DELIVERY MATCHED TO TOTAL DAILY DOSE HISTORY AND THE ACTIVE PROGRAMMED BASAL RATES, THE BOLUSES IN THE HISTORY WERE RECORDED AS PROGRAMMED AND THE PUMP BOLUS TOTALS MATCHED IN THE TOTAL DAILY DOSE. DURING TROUBLESHOOTING, THE REPORTER CONFIRMED BEING ABLE TO PROGRAM AN AIR BOLUS SUCCESSFULLY. THIS EVENT IS REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH AN ALLEGED DELIVERY ISSUE WHICH WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439176 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening