BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1405181 · Received June 18, 2009

    Report

    Report Number
    2183996-2009-01141
    Event Type
    Injury
    Date Received
    June 18, 2009
    Date of Event
    May 17, 2009
    Report Date
    May 19, 2009
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2009, THE PATIENT'S FATHER REPORTED THE PT HAS BEEN RECEIVING E4 (OCCLUSION) ERRORS ON HIS INSULIN INFUSION DEVICE DURING BASAL DELIVERY SINCE ABOUT TWO OR THREE DAYS. HE SAID THAT AS A RESULT THE PT HAS HAD ELEVATED READINGS IN THE 300-400 MG/DL RANGE WITH HIS NORMAL BLOOD GLUCOSE BEING 120 MG/DL. HE HAD NO SYMPTOMS. HE STATED THE PATIENT'S MOST RECENT BLOOD GLUCOSE WAS 280 MG/DL AND HE SWITCHED TO HIS BACKUP DEVICE AND BOLUSED 4 UNITS OF INSULIN TO TREAT HIS READING. TO TROUBLESHOOT, THE FATHER WAS INSTRUCTED TO INSERT A BATTERY AND NEW INSULIN CARTRIDGE INTO THE PRIMARY DEVICE AND ATTACH AN INFUSION SET TUBING. HE WAS ABLE TO PRIME WITHOUT ERROR. THE PT HAS CHANGED HIS INFUSION SET MANY TIMES IN THE PAST 2 DAYS DUE TO THE OCCLUSION. HE HAS USED INFUSION SETS OUT OF 2 DIFFERENT BOXES THAT HAD THE SAME LOT NUMBER AND EXPIRATION DATE AND HAS DISCARDED ANY USED INFUSION SETS. COURTESY INFUSION SETS WITH A DIFFERENT LOT NUMBER WERE SENT TO THE PT. ON FOLLOWUP AT ABOUT 10 DAYS LATER, THE PATIENT'S FATHER STATED THE PT SWITCHED TO THE REPLACEMENT INFUSION SETS AND HAS HAD NO FURTHER ISSUES. HIS BLOOD GLUCOSE HAS RETURNED TO HIS NORMAL RANGE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER INFUSION SET INSULIN INFUSION SET FOZ DISETRONIC MEDICAL SYSTEMS NA 605691

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention INSULIN INFUSION PUMP| INSULIN