BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER

    MDR report key: 3519379 · Received December 13, 2013

    Report

    Report Number
    1823260-2013-07636
    Event Type
    Injury
    Date Received
    December 13, 2013
    Date of Event
    November 25, 2013
    Report Date
    December 20, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION. RESULT PUMP: THE PRODUCT WAS NOT REQUESTED FOR FURTHER INVESTIGATION. THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION. PRODUCTION REPORTS WERE REVIEWED. INFUSION SET: NO SAMPLES WERE RETURNED FOR INVESTIGATION; HOWEVER, THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD FOR LOT #223541 WAS VERIFIED AND FOUND IT WITHIN SPECIFICATIONS. NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE INITIATED AS THE PRODUCT WAS NOT REQUESTED. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 PATIENT REPORTED SHE WAS IN THE HOSPITAL FOR ELEVATED BLOOD GLUCOSE LEVEL; NEEDS ASSISTANCE GETTING INFUSION DEVICE SET UP. PATIENT STATED HER INFUSION DEVICE WAS DISCONNECTED FROM HER BODY FOR ABOUT 2 HOURS ON MONDAY, THE (B)(6). PATIENT REPORTED SHE TOOK A BLOOD GLUCOSE TEST AND IT SHOWED "HI". PATIENT STATED SHE CALLED 911 AND THE EMTS TRANSPORTED HER TO THE HOSPITAL; THEY DID NOT TREAT HER IN THE AMBULANCE. PATIENT REPORTED SHE WAS FEELING SICK BUT DID NOT FEEL SHE COULD SELF-TREAT AND WANTED OUTSIDE ASSISTANCE. PATIENT STATED HER BLOOD GLUCOSE READING WAS "HI" ON THE HOSPITAL METER WHEN SHE ARRIVED; WAS TREATED WITH IV OF UNKNOWN CONTENT AND FOR HER ELEVATED BLOOD GLUCOSE LEVEL. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PATIENT REPORTED HER BLOOD GLUCOSE LEVEL IS UNDER CONTROL NOW AND INFUSION DEVICE IS IN STOP MODE AT THIS TIME. NURSE REPORTED THE DOCTORS AND DCE HAVE SEEN PATIENT AND HAVE TO ADJUST THE INFUSION DEVICE AND WILL HELP HER GET IT STARTED FROM THERE; PATIENT HAS TO "RELEARN" THE INFUSION DEVICE BEFORE SHE CAN LEAVE. PATIENT STATED SHE MAY NOT HAVE CONNECTED THE INFUSION SET TUBING TO THE INFUSION SITE WELL; SHE HAD CHANGED IT A FEW HOURS PRIOR TO NOTICING THAT THEY WERE NOT CONNECTED. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652284 ACCU-CHEK TENDER SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 223541

    Patients

    Seq Age Sex Outcome Treatment
    1 073 YR Hospitalization| R ASPRIN| CIPROFLAXIN| CPAP MACHINE| NOVALOG| LEVATOL| LOVASTATIN| METOPROLOL| BENICAR| LEVOTHYROXINE