BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1855170 · Received September 30, 2010

    Report

    Report Number
    2183996-2010-02006
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    June 21, 2010
    Report Date
    September 7, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2010 CDE REPORTED THE PT STATED SHE WENT TO THE HOSPITAL FOR A PROCEDURE AND HER READINGS WERE AT 63 MG/DL. CDE STATED THE PT REPORTED THE HOSPITAL STAFF HAD HER REMOVE THE INFUSION DEVICE FOR THE DURATION OF THE PROCEDURE WHICH WAS ABOUT 4 HOURS. CDE REPORTED, THE PT STATED THEY TREATED HER WITH SOME DEXTROSE AND WHEN THEY RECHECKED HER READING AFTER THE PROCEDURE, HER READINGS WERE VERY HIGH. CDE STATED PT THOUGHT MAYBE IT WAS A PROBLEM WITH INFUSION SET THAT CAUSED THE ELEVATED READINGS AND THAT SHE REPORTED SHE HAD GONE INTO DKA. CDE REPORTED THE PT WAS NOT USING AN INSERTION ASSIST DEVICE SO SHE GAVE HER ONE TO USE. ON FOLLOW UP CALL TO PT ON (B)(6) 2010, PT REPORTED SHE WAS HAVING REPEATED BENT CANNULAS OFF AND ON FOR A LONG TIME WITH 2 INCIDENTS THAT REQUIRED HOSPITALIZATION. PT STATED IN THE SPRING, SHE WAS DRIVEN TO THE EMERGENCY ROOM BY HER HUSBAND BECAUSE HER BLOOD GLUCOSE READINGS WERE IN THE 500'S MG/DL. PT REPORTED AT THE HOSPITAL HER READINGS REGISTERED OVER 600 MG/DL AND THEY PLACED HER ON AN INSULIN DRIP AND IV WITH BICARBS. PT STATED THE STAFF ASKED HER TO STAY BUT SHE REQUESTED TO BE RELEASED. PT REPORTED SHE WAS RELEASED THAT EVENING WITH HER READING AT 65 MG/DL. PT'S TARGET BLOOD GLUCOSE RANGE IS AROUND 100 MG/DL. PT STATED THERE WERE OTHER BENT CANNULAS AND E4 (OCCLUSION) ERRORS IN BETWEEN, BUT THE NEXT TIME SHE WAS HOSPITALIZED WAS ON (B)(6) 2010. PT REPORTED THE CANNULA WAS BENT; SHE WOULD GET E4 ALERTS WHEN SHE WOULD ATTEMPT TO BOLUS, AND HER READINGS WERE ELEVATED AND SHE COULD NOT BRING THEM DOWN. PT STATED SHE HAD 3 BENT CANNULAS JUST THAT DAY. PT REPORTED HER HUSBAND DROVE HER TO THE HOSPITAL AGAIN WITH THE SAME SYMPTOMS AND THEY TREATED HER WITH AN INSULIN DRIP; SHE DID STAY OVERNIGHT. PT STATED SHE WAS RELEASED THE NEXT DAY WITH HER READING AT 83 MG/DL. THE PT DID MENTION THAT THE LAST INCIDENT SHE WAS DELIRIOUS AFTER SURGERY AND SHE IS NOT SURE WHY, THAT WAS WHEN HER HUSBAND DROVE HER TO THE HOSPITAL. PT REPORTED SHE FEELS THE ELEVATED READINGS HAVE BEEN CAUSED BY THE BENT CANNULAS. PT STATED SHE WAS NOT INSERTING THE INFUSION SETS INTO HER BODY FAST ENOUGH. PT REPORTED THE TRAINER PROVIDED HER WITH AN INSERTION ASSIST DEVICE AND SHE HAS NOT HAD ANY MORE BENT CANNULAS SINCE THAT TIME. PT STATED SHE HAS DISCARDED THE INFUSION SETS WITH THE BENT CANNULAS. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 0E021UF

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R INSULIN INFUSION PUMP| INSULIN