BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2874004 · Received December 14, 2012

    Report

    Report Number
    2531779-2012-14570
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    November 20, 2012
    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. 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

    FOLLOW-UP #1 (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THERE WAS NO VISIBLE DAMAGE TO THE KEYPAD. THE KEYPAD BUTTONS WERE FOUND TO BE RESPONDING PROPERLY TO PRESSES. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS OBSERVED UNDER ALL OF THE BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE FADED. ALSO UNRELATED TO THE COMPLAINT THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE USER GUIDE INSTRUCTS THE PATIENT TO REPLACE THE BATTERY CAP AT LEAST ONCE PER YEAR AND THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE BUTTON PRESSES TO ELICIT A RESPONSE. 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
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR