BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3103249 · Received May 9, 2013

    Report

    Report Number
    2183996-2013-00822
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    February 25, 2013
    Report Date
    August 1, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCTION DATA SHOWS NO DEVIATIONS OF THE SPECIFICATIONS. RESULT AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. AS THE PRODUCT HAS NOT RETURNED FOR EVALUATION, THE COMPLAINT COULD NOT BE INVESTIGATED. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED RECEIVING AN E6 (MECHANICAL ERROR) AND WAS NOT ABLE TO USE HER INFUSION DEVICE PAST THE HALF WAY MARK. PATIENT STATED, HER BLOOD GLUCOSE LEVELS HAVE BEEN ELEVATED AND THAT SHE WAS IN THE HOSPITAL BACK IN (B)(6) 2013 AND ALSO ON (B)(6) 2013. ADVISED PATIENT TO USE A REGULAR ALKALINE BATTERY. PATIENT REPORTED, SHE CHANGED THE BATTERY DURING THE CALL AND THE PISTON ROD ONLY GOES ABOUT HALF THE WAY UP AND THEN THE INFUSION DEVICE DISPLAYS AN E6. HAD PATIENT REMOVE THE CARTRIDGE AND PERFORM A CHANGE THE CARTRIDGE, ADJUSTED THE PISTON ROD AND THE INFUSION DEVICE DISPLAYED AN E6 AGAIN. PATIENT STATED, SHE WENT TO THE HOSPITAL FOR ELEVATED BLOOD GLUCOSE OVER 400 MG/DL. PATIENT REPORTED, SHE WENT TO THE HOSPITAL ABOUT A MONTH AND A HALF AGO AND THEN SHE WENT BACK 3 WEEKS AGO WHERE SHE WAS AT THE HOSPITAL FOR 6-8 HOURS AND THEN SENT HOME; PATIENT'S BLOOD GLUCOSE LEVEL WAS HI AT THAT TIME. PATIENT STATED WHEN SHE WENT TO THE HOSPITAL THE FIRST TIME SHE WAS IN THE HOSPITAL FOR A WEEK AND THEY TOOK HER OFF OF THE INFUSION DEVICE AND TREATED HER WITH INJECTIONS. PATIENT REPORTED, SHE WENT BACK ON THE DEVICE AFTER COMING HOME FROM THE HOSPITAL. PATIENT STATED, SHE WAS TREATED WITH DIET AND INJECTIONS WHILE IN THE HOSPITAL BOTH TIMES. PATIENT REPORTED, SHE DID NOT HAVE A BACKUP DEVICE BUT IS TAKING INJECTIONS WHILE SHE HAS BEEN OFF OF THE DEVICE. ON CALL BACK ON (B)(6) 2013 PATIENT REPORTED, HER BLOOD GLUCOSE LEVELS ARE BACK TO NORMAL. PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 140-150 MG/DL SINCE BEING BACK ON THE INFUSION DEVICE. ON CALL BACK ON (B)(6) 2013 PATIENT REPORTED, SHE FEELS HER BLOOD GLUCOSE LEVELS WERE ELEVATED BECAUSE OF NOT BEING ABLE TO USE THE INFUSION DEVICE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE, BATTERY, AND BATTERY COVER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203384 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR Hospitalization| R LISINOPRIL| NOVOLOG| GABATENTIN| MAGNESIUM| LASIX| FLEXERIL| COREG| LEVOXYL