BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3031280 · Received April 2, 2013

    Report

    Report Number
    2531779-2013-03448
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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: TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT. NO DEFECT WAS FOUND. THE HISTORY SHOWS THE PUMP WAS SUSPENDED ON (B)(4) 2013 11:09; THE SUSPEND WAS CONFIRMED 2 TIMES. DELIVERIES RESUMED (B)(6) 2013 13:36. THE TDD¿S UP UNTIL THE EVENT DATE ON (B)(6) 2013 WERE FOUND TO CORRECTLY REFLECT THE USERS PROGRAMMED RATE. THE ALARM HISTORY CONTAINS ONLY TYPICAL USAGE ALARMS AND WARNINGS. THE HISTORY SHOWS THE PUMP WAS SUSPENDED ON (B)(6) 2013 11:10; DELIVERIES DID NOT RESUME. THE RETURNED PUMP WAS SUBJECT TO A 29 HOUR FLOW ACCURACY TEST; THE PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFIED RANGE. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A CERTIFIED PUMP TRAINER (CPT) CONTACTED ANIMAS ALLEGING THAT THE PATIENT WAS ADMITTED TO THE CRITICAL CARE UNIT OF THE HOSPITAL ON (B)(6) 2013, WITH A DIAGNOSIS OF DIABETIC KETOACIDOSIS. THE PATIENT'S BLOOD GLUCOSE (BG) UPON HOSPITAL ADMISSION WAS REPORTEDLY 700MG/DL WITH KETONES, NAUSEA, AND VOMITING. THE PATIENT WAS DISCONNECTED FROM THE PUMP AND WAS PLACED ON AN INSULIN DRIP AND IV FLUIDS. THE CPT STATED SHE HAD DONE TROUBLESHOOTING OF THE PUMP ON HER OWN AND FOUND NO ISSUES. THE REPORTER DID NOT NOTE ANY SITE OR SET ISSUES AND CONFIRMED BASAL RATES ARE CORRECT. THERE IS CURRENTLY NO INDICATION OR ALLEGATION OF A PUMP MALFUNCTION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED SEVERE HYPERGLYCEMIA OF UNKNOWN CAUSE REQUIRING MEDICAL INTERVENTION WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134703 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| L| R