BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3102242 · Received May 9, 2013

    Report

    Report Number
    2531779-2013-06083
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION CONFIRMED THAT THE BATTERY CAP COIN SLOT IS DAMAGED, MAKING REMOVAL OF THE CAP FROM THE PUMP DIFFICULT. THE BATTERY CAP CONTACTS WERE FOUND TO BE WITHIN REQUIRED SPECIFICATIONS. A REVIEW OF THE PUMP HISTORY SHOWED NO REBOOTS. VISUAL INSPECTION SHOWED NO DAMAGE TO THE BATTERY COMPARTMENT. A TEST BATTERY CAP WAS ABLE TO ATTACH TO THE PUMP WITHOUT ISSUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. NO ALARMS, WARNINGS, OR POWER ISSUES OCCURRED DURING TESTING. THE PUMP COVER WAS REMOVED AND THERE WAS NO INTERNAL DAMAGE OBSERVED. THERE WAS NO DEFECT FOUND WITH THE PUMP; ONLY THE BATTERY CAP DAMAGE WAS IDENTIFIED. THE USER GUIDE INSTRUCTS THE USER TO CHANGE THE BATTERY CAP EVERY THREE TO SIX MONTHS, AND TO BE PREPARED TO GIVE HIM OR HERSELF AN INJECTION IF DELIVERY SHOULD BE INTERRUPTED FOR ANY REASON.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. THE PUMP WAS REPLACED ONLY BECAUSE THE BATTERY CAP COULD NOT BE REMOVED; THERE IS CURRENTLY NO INDICATION OR ALLEGATION OF A PUMP MALFUNCTION AND THE REPORTED INCIDENT WAS DETERMINED TO BE RELATED TO BATTERY CAP DAMAGE. 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, THE PATIENT CONTACTED ANIMAS ALLEGING THAT THE BATTERY CAP'S COIN SLOT WAS DAMAGED AND SHE COULD NOT GET THE BATTERY CAP OFF TO CHANGE THE BATTERY. SUBSEQUENTLY, THE BATTERY DIED AND THE PUMP LOST POWER, AND THE PATIENT'S BLOOD GLUCOSE (BG) ROSE TO 600MG/DL WITH CONFUSION. THE PATIENT REPORTEDLY TOOK A CORRECTION INJECTION AND HER BG CAME DOWN TO 299MG/DL WITH NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT IS NOW ON AN ALTERNATE FORM OF INSULIN DELIVERY. THE PATIENT STATED THAT SHE HAS HAD ISSUES WITH THE BATTERY CAP FOR A WHILE, NOTING THAT THE COIN SLOT IS STRIPPED AND THE CAP IS ALWAYS HARD TO REMOVE AND RE-ATTACH. THE PATIENT REPORTEDLY ATTEMPTED TO REMOVE THE BATTERY CAP WITH A COIN, PLIERS, AND A SCREWDRIVER, WITHOUT SUCCESS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY DUE TO A DAMAGED BATTERY CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204022 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening