BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3061367 · Received April 16, 2013

    Report

    Report Number
    2531779-2013-04342
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWED A MANUAL TIME CHANGE FROM (B)(4) 2013 18:49 TO (B)(4) 2013 17:49; THERE WAS NO PUMP-INITIATED TIME CHANGE PRIOR TO THIS MANUAL RESET. THE TOTAL DAILY DOSE TOTALS ADDED UP CORRECTLY AND REFLECTED THE USERS PROGRAMMED BASAL RATES. ONLY TYPICAL USAGE ALARMS AND WARNINGS WERE OBSERVED. THE PUMP SUCCESSFULLY COMPLETED AND PASSED THE REQUIRED 29-HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATION. A PINKISH CONTRAST WAS OBSERVED ON THE DISPLAY SCREEN. THE PUMP COVER WAS REMOVED AND THE PINK DISPLAY WAS REPLACED WITH A TEST DISPLAY. THE TEST SCREEN WAS FULLY FUNCTIONAL AND WAS FULLY ILLUMINATED WITH NO VISIBLE SIGNS OF DISCOLORATION. THE ALLEGATION THAT THE PUMP CONTRIBUTED TO THE PATIENT'S HYPERGLYCEMIA WAS NOT OBSERVED AND COULD NOT BE CONFIRMED DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #2 SUBMITTED: (B)(4) 2013. 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.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(4) 2013 REPORTING A BLOOD GLUCOSE LEVEL OF 567 MG/DL WITH LETHARGY AND MODERATELY INCREASED THIRST. THE PATIENT REPORTED BOLUSING ALL DAY BUT BLOOD GLUCOSE LEVELS ARE ONLY DOWN TO 425 MG/DL. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162356 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening