BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222472 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10413
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS 09/09/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY SHOWED NO ALARMS, WARNINGS, OR REBOOTS RELATED TO THE COMPLAINT. THE BATTERY COMPARTMENT WAS INTACT; NO DAMAGE WAS OBSERVED. THERE WAS NO EVIDENCE OF MOISTURE FOUND INSIDE THE BATTERY COMPARTMENT. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP. THE BATTERY CAP HEIGHT AND WIDTH MEASUREMENTS WERE NOT WITHIN SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER LOSSES OR BATTERY RELATED WARNINGS OBSERVED. THE PUMP CASE WAS REMOVED AND THERE WAS NO EVIDENCE OF MOISTURE FOUND INSIDE THE PUMP. THE BATTERY TERMINAL CONTACTS WERE INSPECTED AND NO EVIDENCE OF INTERMITTENT CONTACT WAS FOUND. THE ISSUE OF THE INTERMITTENT POWER WAS NOT ABLE TO BE DUPLICATED. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DIM/FADED AND DISCOLORED DISPLAY SCREEN THAT WAS DIFFICULT TO READ. A TEST SCREEN WAS INSERTED AND FOUND TO FUNCTION PROPERLY WITH NO VISIBLE SIGNS OF FADING OR DISCOLORATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE PATIENT CONTACTED ANIMAS ALLEGING THAT ABOUT TWO TO THREE WEEKS AGO THE PUMP POWERED OFF WITHOUT WARNING AND SHE EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) OF 300MG/DL WITH MODERATE THIRST. THE PATIENT WAS REPORTEDLY ABLE TO BOLUS AND BGS WERE STABLE WITHIN ONE TO TWO HOURS. THERE WAS REPORTEDLY NO DAMAGE TO THE PUMP CASING OR THE BATTERY CAP, AND THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION INSIDE THE BATTERY COMPARTMENT. THE PATIENT REPORTEDLY CHANGES THE BATTERY CAP AS NEEDED AND IS ABLE TO TIGHTEN THE BATTERY CAP APPROPRIATELY TO THE PUMP. THERE WERE NO RELATED ALARMS OBSERVED IN THE PUMP HISTORY. THE REPORTED BG EXCURSION DOES NOT MEET CRITERIA FOR A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED POWER ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322139 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR