BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® TENDER INFUSION SET

    MDR report key: 3770758 · Received April 24, 2014

    Report

    Report Number
    1823260-2014-03030
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 29, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. DEVICE WAS NOT REQUESTED TO BE RETURNED.

    Description of Event or Problem · 1

    PATIENT'S DAUGHTER REPORTED PATIENT WAS EXPERIENCING ELEVATED BLOOD GLUCOSE LEVEL OF 566 MG/DL. PATIENT'S TARGET BLOOD GLUCOSE RANGE IS 80- 120 MG/DL. DAUGHTER STATED SHE DOES NOT THINK THE PATIENT WOULD HAVE BEEN ABLE TO CALL FOR ASSISTANCE. DAUGHTER WANTS TO KNOW WHEN PATIENT LAST TOOK A BOLUS; VERIFIED PATIENT TOOK A 10 UNIT BOLUS AT 11:55 AM ON (B)(6) 2014. DAUGHTER REPORTED THAT SHE THEN DISCONNECTED FROM THE INFUSION SITE AND PRIME OUT OF THE END OF THE TUBING, AND A DROP OF INSULIN CAME OUT BY THE LUER LOCK; TIGHTENED THE LUER LOCK AT THAT TIME AND THEN INSULIN FLOWED OUT OF THE END OF THE TUBING AND THEN RECONNECTED TO THE INFUSION SITE. DAUGHTER REPORTED SHE PROGRAMMED A 10 UNIT BOLUS; SUCCESSFULLY DELIVERED. DAUGHTER STATED THE PATIENT WAS ALSO UNDER ADDITIONAL STRESS. ON CALL BACK ON (B)(6) 2014 DAUGHTER CLARIFIED THE LEAK ORIGINATED FROM THE LUER LOCK. DAUGHTER STATED SHE DISCOVERED THE LEAK DURING TROUBLESHOOTING. DAUGHTER REPORTED SHE DID NOT THINK SHE HEARD AN AUDIBLE CLICK WHEN ATTACHING THE HEAD SET TO THE TUBE SET. DAUGHTER STATED SHE THINKS THE LEAK AND STRESS WERE THE CAUSE OR CONTRIBUTION TO THE PATIENT'S ELEVATED BLOOD GLUCOSE LEVEL. INFUSION SET WAS NOT REQUESTED TO BE RETURNED FOR INSPECTION/EVALUATION; PATIENT CONTINUED TO USE THE PRODUCT WITH NO FURTHER ISSUES. NO PRODUCT RETURN WAS REQUESTED FOR EVALUATION SINCE IT NO LONGER LEAKED ONCE THE LUER LOCK WAS TIGHTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249413 ACCU-CHEK ® TENDER INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5006677

    Patients

    Seq Age Sex Outcome Treatment
    1 083 YR Required Intervention NOVALOG