BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3032956 · Received April 3, 2013

    Report

    Report Number
    2531779-2013-03476
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. THE PUMP SUCCESSFULLY COMPLETED AND PASSED THE REQUIRED 29 HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATION. REVIEW OF THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO CORRECTLY REFLECT THE USER'S PROGRAMMED BASAL RATES. ONLY NORMAL USAGE ALARMS AND WARNINGS WERE OBSERVED IN THE ALARM HISTORY.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, STATING THAT THE PATIENT WAS HAVING LOW BLOOD GLUCOSE LEVELS. THE REPORTER STATED THAT THE PATIENT WAS MORE ACTIVE THE PREVIOUS DAY WHEN THE PATIENT HAD A LOW; THE PATIENT REPORTEDLY WAS PLAYING VOLLEYBALL THEN DID A SITE CHANGE AND HAD A BLOOD GLUCOSE OF 90 MG/DL PRIOR TO A MEAL AND AFTER EATING THE PATIENT'S BLOOD GLUCOSE DECREASED TO 50 MG/DL. THE PATIENT WAS REPORTEDLY TREATED WITH ORAL CARBOHYDRATE AND A DECREASED BASAL RATE AND THE BLOOD GLUCOSE RESOLVED TO THE LOW 100 MG/DL RANGE. THE REPORTER ALSO STATED THAT THE PATIENT WENT TO THE SCHOOL NURSE APPEARING CONFUSED, UNKNOWN BLOOD GLUCOSE LEVEL AT THAT TIME, THE PATIENT WAS GIVEN ORAL CARBOHYDRATE AND THE PATIENT'S BLOOD GLUCOSE WAS LATER MEASURED AT 74 MG/DL AND 110 MG/DL; THE REPORTER INDICATED THAT THE EVENT WAS AFTER THE PATIENT HAD BEEN OUTSIDE PLAYING BALL WITH FRIENDS. THE REPORTER STATED THAT THE LOW BLOOD GLUCOSE EVENTS MAY HAVE BEEN IN PART RELATED TO SITE CHANGES; THE PATIENT REPORTED ROTATED SITES USING ONLY USING THE BUTTOCKS. THE REPORTER WAS ADVISED TO KEEP LOGS OF VARIABLES THAT MAY BE AFFECTING THE BLOOD GLUCOSE LEVELS AND REVIEW WITH A HEALTH CARE PROVIDER TO DETERMINE IF INSULIN REGIMEN ADJUSTMENTS MAY BE NEEDED. THIS EVENT IS REPORTED WITH THE CONCLUSION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA OF UNCLEAR CAUSE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137257 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Life Threatening