BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3223052 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10493
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE NOT YET BEEN RETURNED. IF THE PRODUCT(S) ARE RETURNED, ANM WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/11/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/24/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP POWERED ON WITH A CONTINUOUS AUDIBLE BEEP AND VIBRATION DUE TO INTERNAL MOISTURE DAMAGE AND THE PUMP WAS UNRESPONSIVE. A TEST BATTERY CAP WAS TRIED BUT THE PUMP STILL POWERED IN THE SAME MANNER. A REVIEW OF THE BLACK BOX SHOWED NO ALARMS RELATED TO COMPLAINT, HOWEVER, TWO PUMP REBOOTS FOLLOWING A REPLACE BATTERY ALARM WERE OBSERVED IN THE BLACK BOX ON 06/24/2013. THE BATTERY COMPARTMENT WAS FOUND TO BE INTACT WITH NO CRACKS. THE BATTERY CAP IS ABLE TO FULLY TIGHTEN. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE THE BATTERY COMPARTMENT AND ON THE UNDERSIDE OF THE BATTERY CAP. A LEAK TEST SHOWED A LEAK AT THE CASE SEAL. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF ADDITIONAL MOISTURE CONTAMINATION WAS IDENTIFIED INSIDE THE PUMP. ADDITIONAL TESTING WAS NOT ABLE TO BE PERFORMED DUE TO INTERNAL MOISTURE DAMAGE. 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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING COMPLETE POWER LOSS RESULTING FROM MOISTURE INGRESS. THE DAY BEFORE THE COMPLAINT, POWER ISSUES BEGAN AND CONDENSATION WAS NOTED ON THE CARTRIDGE. THE MOST RECENT LOSS OF POWER ALSO OCCURRED DURING THIS TIME. ADDITIONALLY, THE BATTERY COMPARTMENT IS RUSTED/CORRODED AND CONTAINS INSULIN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322134 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR