BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1071413 · Received July 7, 2008

    Report

    Report Number
    2183996-2008-01000
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 19, 2008
    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
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED ELEVATED BLOOD GLUCOSE READINGS SINCE THE PREVIOUS NIGHT. SHE STATED THAT AT 5:00 PM ON THE DAY BEFORE, HER BLOOD GLUCOSE MEASURED 300 MG/DL AND SHE BOLUSED 7 UNITS OF INSULIN AND ATE A SNACK BEFORE BED. SHE STATED THAT AT 2 AM, HER BLOOD GLUCOSE MEASURED "HI" ON HER BLOOD GLUCOSE MONITOR AND SHE INJECTED 15 UNITS OF INSULIN VIA SYRINGE. AT 6:00 AM, HER BLOOD GLUCOSE MEASURED 258 MG/DL AND SHE ATE BREAKFAST AND BOLUSED 5 UNITS OF INSULIN. AT 12:00 PM, HER BLOOD GLUCOSE MEASURED 330 MG/DL AND SHE ATE LUNCH AND INJECTED 15 UNITS OF INSULIN VIA SYRINGE. AT 3:20 PM, HER BLOOD GLUCOSE MEASURED 400 MG/DL. THE PT CONFIRMED THAT HER BASAL RATE TOTALS WERE CORRECT AND THE TIME AND DATE WERE PROGRAMMED CORRECTLY. SHE STATED THERE WERE NO AIR BUBBLES OR LEAKS IN THE SYS. SHE REPORTED THAT SHE WAS TAKING ANTIBIOTICS FOR A COLD. TO TROUBLESHOOT, THE PT WAS INSTRUCTED TO DISCONNECT FROM HER INFUSION SITE AND TO BOLUS 1 UNIT. SHE STATED THAT NO INSULIN DRIPPED FROM THE INFUSION TUBING. THE PT WAS INSTRUCTED TO PERFORM THE CHANGE CARTRIDGE PROCEDURE AND PERFORMED TWO CYCLES OF PRIMING AND STILL NO INSULIN DRIPPED FROM THE INFUSION TUBING. THE PT WAS INSTRUCTED TO ATTACH A NEW INFUSION TUBING AND WAS ABLE TO PRIME SUCCESSFULLY. UPON F/U ON THE DAY AFTER THE ORIGINAL DATE, THE PT REPORTED THAT HER BLOOD GLUCOSE HAD RETURNED TO NORMAL. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PROD 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 UNK

    Patients

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