BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5946931 · Received September 13, 2016

    Report

    Report Number
    2531779-2016-25090
    Event Type
    Injury
    Date Received
    September 13, 2016
    Report Date
    August 20, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/7/2016 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/15/2016 WITH THE FOLLOWING FINDINGS: NO DEFECT FOUND. TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT. THE BLACK BOX SHOWS THE PUMP WAS MANUALLY SUSPENDED ON (B)(6) 201610:47; DELIVERIES NEVER RESUMED. THE PUMP WAS MANUALLY SUSPENDED ON (B)(6) 2016, DELIVERIES RESUMED AT (B)(6) 2016 19:35..PUMP WAS EXERCISED FOR 24HRS WITH A 2.0U/HR BASAL RATE; AT END TESTING THE BASAL HISTORY CORRECTLY SHOWED 2.0U AND TDD SHOWED 48.0U..THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TESTING WITH NO DELIVERY DEFECTS FOUND. PUMP FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY..NO DELIVERY INTERRUPTIONS OR ALARMS OCCURRED DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIIMAS AND ALLEGED THE PATIENT HAD BEEN HOSPITALIZED ON (B)(6) 2016 WITH A BLOOD GLUCOSE (BG) OF 500MG/DL, WITH LARGE KETONES, NAUSEA ,VOMITING, AND EXTREME THIRST. TREATMENT INCLUDED IV FLUIDS AND INSULIN INJECTIONS. DURING TROUBLESHOOTING, CUSTOMER SUPPORT (CS) FOUND THAT THE BASAL HISTORY DID NOT MATCH THE ACTIVE BASAL PROGRAM. THE PATIENT HAS DISCONTINUED PUMP USE. CS ATTRIBUTED THE EXCURSION TO AN INACCURATE DELIVERY ISSUE. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT EXPERIENCED HYPERGLYCEMIA DUE TO INACCURATE DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598924 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization