BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2962211 · Received February 14, 2013

    Report

    Report Number
    2531779-2013-01802
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: UNUSUAL POWERS ON RESETS ARE OBSERVED IN THE BLACK BOX DATA. BATTERY CAP THREADS ARE INTACT. NO CRACK WAS OBSERVED TO THE BATTERY COMPARTMENT. THE BATTERY CAP IS ABLE TO SECURELY FIT TO THE PUMP. CAP CONTACTS MEASUREMENTS WERE TAKEN AND FOUND:WITHIN SPECIFICATION. BATTERY CAP WAS TIGHTEN UNTIL FLUSH AGAINST PUMP AND SLOWLY UNSCREWED ½ TURN WITH NO REBOOTS. THE BATTERY CAP IS ABLE TO MAINTAIN AN ELECTRICAL CONNECTION. THE PUMP POWERS UP WITH AUDIBLE SOUND AND VIBRATION, BUT THE DISPLAY IS BLANK: UNABLE TO VERIFY ALL STEPS TO INVESTIGATE INTERMITTENT POWER COMPLAINT. THE COVER WAS POPPED OFF; MOISTURE CORROSION WAS FOUND ON THE DISPLAY SCREEN FLEX/CONNECTOR AND ON THE PCB. UNRELATED TO THIS COMPLAINT, THE AUDIO BOLUS BUTTON COVER WAS OBSERVED TO BE DETACHED AND MISSING, UNABLE TO TAKE THE AUDIBLE TEST READING.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE PUMP REPORTEDLY POWERED OFF WITHOUT USER INTERVENTION. 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
    64910 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR