BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242229 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11669
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ANIMAS HAS REQUESTED THE SUBJECT PRODUCTS TO BE RETURNED FOR EVALUATION HOWEVER THE PRODUCTS HAVE NOT YET BEEN RETURNED OR EVALUATED. IF ANIMAS RECEIVES THE PRODUCT ANIMAS WILL INFORM THE FDA OF ANY PRODUCTS THAT FAIL EVALUATION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 11/04/2013 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/24/2013 WITH THE FOLLOWING FINDINGS: PUMP POWERS TO THE VERIFY SCREEN PER NORMAL OPERATION. TWO BATTERY COMPARTMENT CRACKS OBSERVED, ONE IN THREAD AREA AND ONE BELOW GRIP PAD. EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE BATTERY COMPARTMENT. THE BATTERY CAP IS UNABLE TO FULLY TIGHTEN DUE TO DAMAGED CAP THREADS AND BATTERY COMPARTMENT CRACK. A TEST CAP WAS USED AND WAS ABLE TO FULLY TIGHTEN. A POWER LOSS WAS NOTT OBSERVED. THE PUMP WAS EXERCISED FOR 24 HOURS. NO POWER LOSS OR BATTERY RELATED WARNINGS WERE OBSERVED. A LEAK TEST SHOWS LEAK AT CRACK IN BATTERY COMPARTMENT. PUMP CASE WAS REMOVED, EVIDENCE OF MOISTURE CONTAMINATION IDENTIFIED INSIDE OF PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER STATED THAT THE PATIENT WENT SWIMMING AND NOW THE PUMP WILL NOT POWER BACK ON. THE REPORTER CONFIRMED THERE WAS MOISTURE IN THE BATTERY COMPARTMENT. 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
    344061 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR