BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2921684 · Received January 11, 2013

    Report

    Report Number
    2183996-2012-02135
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 12, 2012
    Report Date
    July 1, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. PRODUCTION DATA WAS REVIEWED AND COMPLY WITH SPECIFICATIONS. THE ISSUE REPORTED BY THE PATIENT COULD NOT BE DUPLICATED. PRODUCT NOT RETURNED.

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. RESULT PUMP: THE DELIVERY ACCURACY AND THE OCCLUSION LIMITS WERE TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSIS TEST AND MEET THE SPECIFICATION. ALL ALARM FUNCTIONS WERE TESTED SUCCESSFUL AND NO MALFUNCTION COULD BE OBSERVED DURING THE TECHNICAL INVESTIGATION. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. HISTORY LIST: THE CUSTOMER SET THE PUMP IN STOP MODE FROM (B)(6) 18:58 TO (B)(6) 13:50 IN 2012. IN THIS TIME PERIOD, THE PUMP DELIVERED NO INSULIN AS RESULT THE DAY TOTAL DECLINED TO 25.4 IU ON (B)(6) 2012. ADDITIONAL SINCE (B)(6) 2012, THE CUSTOMER DID NOT PROGRAM BOLIS VIA THE PUMP THEREFORE THE PUMP DELIVERED THE BASAL RATE OF 60.0 IU DAILY ONLY. ON (B)(6) 2012 17:12 THE CUSTOMER STOPPED USING THE PUMP. CONSUMABLES ADAPTER: NO ADAPTER WAS RECEIVED FOR INVESTIGATION. CARTRIDGE: SINCE NO MATERIAL HAS BEEN RETURNED FROM THE CUSTOMER AND NO LOT NUMBER IS KNOWN, NO INVESTIGATION COULD BE PERFORMED. INFUSION SET: NO MATERIAL WAS RECEIVED FOR INVESTIGATION. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD FOR LOT #226324 WAS VERIFIED AND FOUND IT WITHIN SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, PATIENT'S NURSE CALLED TO GATHER THE CUSTOMER INSULIN SENSITIVITY AND CORRECT RATIO OFF THE INFUSION DEVICE. REVIEWED WITH THE NURSE THAT ONLY THE BASAL RATES ARE STORED IN THE INFUSION DEVICE AND OTHER PARAMETERS ARE ON THE PDA DEVICE. NURSE REPORTED PATIENT WAS IN THE HOSPITAL ON AN INSULIN DRIP AND WILL BE INTRODUCED BACK TO PUMP THERAPY. NURSE STATED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ELEVATED BLOOD GLUCOSE LEVELS BUT NO DKA WAS REPORTED. ON CALL BACK ON (B)(6) 2012 PATIENT REPORTED HER ELEVATED BLOOD GLUCOSE READINGS BEGAN (B)(6), MIGHT HAVE STARTED ON (B)(6) 2012. PATIENT REPORTED SHE WENT TO THE DOCTOR FOR ELEVATED BLOOD GLUCOSE AND BREATHING CONCERNS. PATIENT STATED HER BLOOD GLUCOSE LEVEL WAS 620 MG/DL ON THE DOCTOR'S METER ON (B)(6) 2012. PATIENT REPORTED HER BLOOD GLUCOSE LEVEL AT 10 AM THAT MORNING WAS 255 MG/DL AND SHE TOOK A BOLUS BASE ON THE READING. PATIENT STATED SHE WAS ABLE TO BOLUS WITHOUT ASSISTANCE. PATIENT REPORTED SHE HAS EXPERIENCED ELEVATED BLOOD GLUCOSE READINGS FOR 7 WEEKS. PATIENT'S TARGET BLOOD GLUCOSE RANGE IS 100-150 MG/DL. PATIENT STATED SHE WAS ON AN INSULIN DRIP WHILE IN THE HOSPITAL. PATIENT REPORTED WHILE SHE WAS IN THE HOSPITAL THE INFUSION SET CAME OUT OF HER STOMACH BECAUSE THE INFUSION SET TUBING WAS TOO SHORT; HOSPITAL GAVE HER THE WRONG INFUSION SET. ADVISED PATIENT TO SWITCH TO THE BACKUP INFUSION DEVICE. PATIENT STATED SHE ACCIDENTALLY DROPPED THE INFUSION DEVICE WHILE IT WAS IN THE CASE; CASE CLIP BROKE. PATIENT REPORTED THE INFUSION DEVICE ISN'T DAMAGED. PATIENT STATED SHE DIDN'T NOTICE THE INFUSION HEADSET HAD COME OUT OF THE STOMACH UNTIL SHE FELT IT WAS WET. PATIENT REPORTED SHE TESTED AND HER BLOOD GLUCOSE READING WAS ELEVATED DUE TO THE LEAK. ON FOLLOW UP CALL ON (B)(6) 2012, PATIENT REPORTED SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 AND SWITCHED TO THE BACKUP INFUSION DEVICE LAST NIGHT AND THEN THIS MORNING HER BLOOD GLUCOSE LEVEL RETURNED TO NORMAL RANGE OF 134 MG/DL AT 9 AM. PATIENT DISCARDED THE ORIGINAL CARTRIDGE AND INFUSION SET WHILE IN THE HOSPITAL. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE, CURRENT INSULIN CARTRIDGE, INFUSION SET AND INFUSION ADAPTER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16882 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP| DATE OF THERAPY: UNK