BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 2893423 · Received October 22, 2008

    Report

    Report Number
    2183996-2008-01615
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    April 1, 2008
    Report Date
    October 11, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PT REPORTED EXPERIENCING OCCLUSION (E4) ERRORS DURING BASAL AND BOLUS DELIVERY AND DURING PRIMING. SHE STATED THAT THIS HAS BEEN AN ONGOING ISSUE SINCE SHE RECEIVED THIS SHIPMENT OF INFUSION SETS IN (B)(6) 2008. THE PT CHANGES HER INFUSION SITE EVERY 3 DAYS, BUT MUST CHANGE IT MORE OFTEN DUE TO OCCLUSIONS. SHE STATED THAT SHE CHANGED THE INFUSION SITE AND TUBING ON (B)(6) 2008 AND AT 1:00 AM ON (B)(6) 2008, SHE RECEIVED ANOTHER E4 ERROR. SHE CHANGED THE INSULIN CARTRIDGE, ADAPTER, INFUSION SITE, AND TUBING AND EXPERIENCED ANOTHER E4 JUST PRIOR TO THE REPORT. TO TROUBLESHOOT, THE PT WAS INSTRUCTED TO REMOVE THE INFUSION TUBING AND PRIME THROUGH THE ADAPTER. SHE WAS ABLE TO DO SO WITHOUT ERROR. SHE ATTACHED A NEW INFUSION TUBING AND WAS ABLE TO PRIME WITHOUT ERROR. SHE THEN RECONNECTED TO THE INFUSION SITE AND BOLUSED 4 UNITS OF INSULIN WITHOUT ERROR. HER BLOOD GLUCOSE WAS ELEVATED TO 183 MG/DL. HER NORMAL BLOOD GLUCOSE LEVEL AT THAT TIME OF DAY IS 60-90 MG/DL. UPON FOLLOW UP ON (B)(6) 2008, THE PT STATED THAT SHE HAD NO FURTHER ISSUES SINCE CHANGING THE TUBING. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX INFUSION SET INSULIN INFUSION SET LZG DISETRONIC MEDICAL SYSTEMS NA 7K175UF

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention INSULIN INFUSION PUMP| INSULIN