BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3872657 · Received June 13, 2014

    Report

    Report Number
    2531779-2014-17016
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 07/11/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/03/2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA DID NOT FIND ANY ACTIVITIES OUT OF NORMAL USE. TOTAL DAILY DELIVERY REFLECTS THE USER¿S PROGRAMMED BASAL RATE. ON INVESTIGATION, THE PUMP POWERED UP AND PERFORMED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE WERE EXECUTED WITHOUT INCIDENTS. THE PUMP DELIVERY ACCURACY WAS WITHIN REQUIRED SPECIFICATIONS. THE BOLUS DELIVERY EXERCISES WERE COMPLETED AND RECORDED CORRECTLY. THE REPORTED INACCURATE DELIVERY ISSUE WAS NOT VERIFIED IN THE BLACK BOX OR DUPLICATED IN THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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

    ON (B)(6) 2014, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT HAD BEEN HOSPITALIZED ON (B)(6) 2014 WITH DIABETIC KETOACIDOSIS , HYPERGLYCEMIA WITH AN UNSPECIFIED BLOOD GLUCOSE LEVEL, AND SYMPTOMS OF DEHYDRATION. WHILE HOSPITALIZED, THE PATIENT WAS REPORTEDLY TREATED WITH INSULIN VIA INJECTION AS WELL AS IV FLUIDS. AT THE TIME OF THE CALL, THE PATIENT WAS REPORTED AS STILL BEING IN THE HOSPITAL AND HAD DISCONTINUED PUMP THERAPY. DURING THE CALL WITH A CUSTOMER TECHNICAL SERVICE REPRESENTATIVE, THE REPORTER REVIEWED THE PUMP AND DETERMINED THAT THE SETTINGS WERE CORRECT AND THE BASAL AND BOLUS HISTORY MATCHED WHAT WAS RECORDED IN THE PUMP. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT DUE TO AN UNIDENTIFIED ISSUE WHILE ON THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349280 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| L