BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3091409 · Received May 3, 2013

    Report

    Report Number
    2531779-2013-05825
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP¿S HISTORY SHOWED EVIDENCE OF REBOOTS ON THE REPORTED FAILURE DATE. THE PUMP WAS RETURNED WITH A CRACKED BATTERY COMPARTMENT AND AN UNDAMAGED BATTERY CAP; HOWEVER THE CAP WAS UNABLE TO TIGHTEN ON SECURELY. A TEST CAP WAS USED AND WAS ABLE TO TIGHTEN ON FULLY. THE PUMP POWERED ON AND DISPLAYED THE VERIFY SCREEN. THE PUMP WAS TESTED FOR 24 HOURS WITH NO POWER INTERRUPTION. THE PUMP COVER WAS REMOVED AND NO INTERNAL MOISTURE OR DAMAGE WAS FOUND TO THE POWER CIRCUIT OR BATTERY FLEX. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DIM AND DISCOLORED DISPLAY SCREEN. A TEST SCREEN WAS INSTALLED AND DISPLAYED NORMALLY. ADDITIONALLY, THE UP ARROW AND CONTRAST KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE DURING TESTING. THE KEYPAD COVER WAS REMOVED; CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS AND THE UP ARROW AND CONTRAST KEYPAD BUTTONS WERE MISALIGNED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. 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
    194593 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR