BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRONPLUS POWER PACK

    MDR report key: 1012842 · Received March 11, 2008

    Report

    Report Number
    2183996-2008-00310
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K022831
    Removal / Correction Number
    Z-1413-6
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT REPORTED HER INSULIN INFUSION DEVICE BEGAN TO BEEP CONTINUOUSLY AND DISPLAY A "77" AND "3.00" ON ITS SCREEN. SHE STATED THE POWER PACK IN THE DEVICE HAD BEEN IN USE FOR A LOT LONGER THAN 2 WEEKS. TO TROUBLESHOOT, THE PATIENT WAS INSTRUCTED TO DISCONNECT FROM HER INFUSION HEADSET AND CHECK THE LOT NUMBER AND EXPIRATION DATE ON HER POWER PACK. SHE STATED SHE COULD NOT SEE EITHER OF THESE NUMBERS, BUT WAS ABLE TO IDENTIFY THE REFERENCE NUMBER ON THE PACKAGING AS BEING PART OF THE RECALLED BATTERIES. THE PATIENT STATED, SHE WAS AWARE OF THE RECALL BUT HAD NEVER HAD AN ISSUE WITH HER POWER PACKS BEFORE. THE PATIENT WAS INSTRUCTED TO INSERT A DIFFERENT POWER PACK INTO HER DEVICE WHICH RESOLVED THE ISSUE. THE PATIENT WAS INSTRUCTED TO DISCARD ALL RECALLED POWER PACKS AND USE ONLY CORRECTED POWER PACKS. THE PATIENT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-TRONPLUS POWER PACK INSULIN INFUSION PUMP BATTERY LZG DISETRONIC MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION PUMP| INSULIN| INSULIN INFUSION SET