BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3010402 · Received March 19, 2013

    Report

    Report Number
    2531779-2013-02812
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: TESTING CONFIRMED IN THE HISTORY BUT COULD NOT DUPLICATE THE BATTERY ALARM ISSUE. BEGINNING (B)(4) 2013 REPLACE BATTERY 128-FE80 AND FB80 ALARMS OBSERVED IN THE BLACK BOX. PUMP HISTORY SHOWS BASAL DELIVERING UNTIL ALARMS BEGAN AT 12:27PM (B)(4) 2013. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED USER'S PROGRAMMED BASAL RATES. PUMP PASSED 29 HOUR FLOW ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. NO ALARMS OCCURRED DURING TESTING. THE PUMP ELECTRICAL CURRENT DRAWS WERE TESTED AND WERE WITHIN SPECIFICATIONS.

    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. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, INDICATING THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE LEVELS IN THE 300-400MG/DL RANGE WITH NAUSEA AND VOMITING. THE PUMP REPORTEDLY EMITTED A REPLACE BATTERY WARNING AFTER THE PATIENT CHANGED THE BATTERY AND REQUIRED THE PATIENT TO RE-BOOT THE PUMP IN ORDER TO COMPLETE A REWIND, LOAD AND PRIME. THE PATIENT INDICATED THAT THEIR BLOOD GLUCOSE LEVELS ROSE DUE TO THIS. THE PATIENT REPORTEDLY CAME OFF OF THE PUMP AND WAS ABLE TO RETURN THEIR BLOOD GLUCOSE LEVELS TO THEIR TARGET RANGE WITH A BACKUP PUMP. THIS REPORT IS BEING MADE BASED ON THE INDICATION THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS RELATED TO RESPONSE TO REPLACE BATTERY WARNINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114018 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening