BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4973321 · Received August 5, 2015

    Report

    Report Number
    2531779-2015-26990
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    December 27, 2012
    Report Date
    July 20, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 09/02/2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWED AN UNCONFIRMED REPLACE CARTRIDGE ALARM ON (B)(6) 2012 AT 09:35, FOLLOWED BY PUMP REBOOT ON (B)(6) 2012 AT 09:40; DELIVERIES NEVER RESUMED. THERE WERE MULTIPLE MANUALLY PUMP SUSPENSIONS OBSERVED. THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. THERE WERE NO ERRORS, ALARMS OR WARNINGS DURING TESTING. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY SCREEN HAD A PINKISH CONTRAST. ALSO UNRELATED, THE PUMP HAD NO VIBRATION. THE PUMP¿S COVER WAS REMOVED AND THE VIBRATE MOTOR PINS WERE NOT MAKING A CONNECTIONS WITH THE PRINTED CIRCUIT BOARD. THE PINS WERE ADJUSTED AND THE VIBRATION RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON (B)(6) 2012, THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) OVER 1300 MG/DL WITH SYMPTOMS OF DEHYDRATION, CHEST PAIN AND LARGE KETONES ASSOCIATED WITH AN INACCURATE DELIVERY ISSUE. REPORTEDLY, THE PATIENT DISCONTINUED THE INSULIN PUMP, WAS HOSPITALIZED WITH DIABETIC KETOACIDOSIS AND TREATED WITH INSULIN VIA INJECTION, IV FLUIDS AND OTHER UNSPECIFIED TREATMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED A SERIOUS BG EXCURSION BECAUSE OF AN INACCURATE DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513813 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R