BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3223714 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10436
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/09/2013 WITH THE FOLLOWING FINDINGS: DURING EVALUATION, THE PUMP DID NOT POWER ON. DUE TO INTERNAL MOISTURE DAMAGE THE PUMP WAS UNRESPONSIVE. THE PUMP HAD NO AUDIBLE TONE, NO VIBRATION AND NO DISPLAY DUE TO INTERNAL MOISTURE DAMAGE. THE BATTERY COMPARTMENT WAS OBSERVED TO HAVE CRACKED THREADS. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE BATTERY COMPARTMENT. THE BATTERY CAP WAS NOT ABLE TO FULLY TIGHTEN TO THE PUMP DUE TO THE BATTERY COMPARTMENT CRACK. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION FOUND ON THE UNDERSIDE OF THE BATTERY CAP. THE PUMP WAS STILL UNRESPONSIVE WHEN TESTED WITH A TEST CAP. ADDITIONAL TESTING WAS NOT ABLE TO BE PERFORMED DUE TO INTERNAL MOISTURE. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF ADDITIONAL MOISTURE CONTAMINATION WAS OBSERVED INSIDE OF THE PUMP. 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. (B)(4).

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER STATED WHEN SHE WAS CHANGING THE BATTERY SHE FOUND CORROSION IN THE BATTERY COMPARTMENT. THE REPORTER STATED SHE FREQUENTLY SWIMS WITH PUMP. 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
    323954 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR