BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2883905 · Received December 21, 2012

    Report

    Report Number
    2531779-2012-14994
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    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) 2012 REPORTING BLOOD GLUCOSE LEVELS FROM 1.7MMOL/L TO AS HIGH AS 27MMOL/L THIS PAST WEEK. THE REPORTER STATED THAT THE PATIENT JUST RECEIVED A NEW PUMP TO REPLACE THE OLD PUMP. THE REPORTER INDICATED THAT THE DAY THAT THE PATIENT GOT THE PUMP BLOOD GLUCOSE LEVELS BECAME UNCONTROLLED. THE REPORTER STATED THAT THE PATIENT'S CURRENT BLOOD GLUCOSE WAS 18MMOL/L WITH SEVERE NAUSEA, PROJECTILE VOMITING, AND HIGH KETONES. THE REPORTER STATED THAT AFTER THE PREVIOUS CALL TO CUSTOMER SUPPORT THE SYSTEM WAS REVIEWED AND CONFIRMED VERIFIED THAT THERE WERE NO AIR BUBBLES IN THE SYSTEM; THE PUMP SETTINGS WERE DOUBLE CHECKED AND CONFIRMED CORRECT. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED ERRATIC BLOOD GLUCOSE LEVELS RELATED TO AN ALLEGATION OF A PUMP DELIVERY ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening