BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3052101 · Received April 11, 2013

    Report

    Report Number
    2531779-2013-04040
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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: THE COMPLAINT COULD NOT BE DUPLICATED DURING THE INVESTIGATION. THE RETURNED PUMP WAS SUBJECT TO A (B)(4) FLOW ACCURACY TEST; THE PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFIED RANGE. THERE WERE NO ALARMS RELATED TO THE COMPLAINT IN THE BLACK BOX OR ALARM HISTORY, ONLY TYPICAL USAGE ALARMS AND WARNINGS WERE OBSERVED. THE METER WAS NOT RETURNED WITH 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.

    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. 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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT AT 3 A.M. ON (B)(6) 2013, SHE HAD A BLOOD GLUCOSE (BG) SO LOW THAT DID NOT REGISTER ON METER. HER HUSBAND CALLED EMS, WHO GAVE HER "BAGS OF SUGAR" TO GET BG UP. PATIENT STATES SHE WAS UNCONSCIOUS. HER TARGET BG IS BETWEEN 100MG/DL-110MG/DL, AND HER BG CAME UP TO THE 100'S MG/DL. SHE WAS FINE AFTERWARD AND DID NOT REQUIRE HOSPITAL ATTENTION. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED PUMP AND ADVISED PATIENT THAT HISTORY ADDS UP PROPERLY. PER REVIEW OF BASAL SEGMENTS, PATIENT STATES THEY WERE PROGRAMMED AS DESIRED. REVIEWED PUMP HISTORIES, THERE WERE NO DISCREPANCIES FOUND, BOLUS AND BASAL AMOUNTS ADD UP WITH TDD, NO RELATED ALARMS. THE PATIENT ALLEGES THE LOW BG'S ARE BEING CAUSED BY TOO MUCH BASAL INSULIN. BASAL RATE IS 1.8U/HR, PATIENT STATES SHE WAS GETTING 4.8U/HR, BUT THIS COULD NOT BE CONFIRMED IN BASAL HISTORY. ALTHOUGH CTS FOUND NO DEFECT IN PUMP, PATIENT ALLEGES HER HEALTH CARE PROVIDER WANTS PUMP REPLACED FOR PATIENT'S LOW BG'S. THIS COMPLAINT IS BEING REPORTED BECAUSE A PATIENT ON PUMP THERAPY EXPERIENCED HYPOGLYCEMIA REQUIRING MEDICAL ASSISTANCE, RELATED TO AN ALLEGED PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155452 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening