BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3100569 · Received May 8, 2013

    Report

    Report Number
    2183996-2013-00810
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 26, 2013
    Report Date
    September 18, 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
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE USED RETURNED HEAD SET AND TRANSFER SET WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. ADDITIONALLY THE DIMENSIONAL ACCURACY OF THE LUER WAS TESTED. UNDER THE MICROSCOPE IT WAS RECOGNIZED THAT THE LUER WAS CRACKED BY EFFECTS OF EXCESSIVE FORCE. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT DESCRIBING A LEAKY ON THE INFUSION SET CANNOT BE VERIFIED, THE MATERIAL MEETS PRODUCT SPECIFICATIONS. RESULT INFUSION SET: NO SAMPLE WAS RECEIVED FOR EXAMINATION. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND CLICK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD FOR LOT #05011492 WAS VERIFIED AND FOUND IT WITHIN SPECIFICATIONS. CARTRIDGE: SINCE NO MATERIAL HAS BEEN RETURNED FROM THE CUSTOMER AND NO LOT NUMBER IS KNOWN, NO INVESTIGATION COULD BE PERFORMED. THEREFORE THE COMPLAINT CANNOT BE VERIFIED. 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. ADAPTER: THE ADAPTER IS CONTAMINATED. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 PATIENT REPORTED BEING ADMITTED TO THE HOSPITAL FOR DIABETIC KETOACIDOSIS. PATIENT STATED ON (B)(6) 2013 SHE HAD LUNCH AND AT 2 PM CHECKED HER BLOOD GLUCOSE LEVEL WITH A READING OF 515 MG/DL. PATIENT DOES NOT HAVE A NORMAL RANGE BECAUSE SHE IS A BRITTLE DIABETIC, BUT HER NORMAL RANGE IS LOWER. PATIENT REPORTED SHE GAVE HERSELF A BOLUS AND A FEW HOURS LATER SHE HAD A BLOOD GLUCOSE READING OF 505 MG/DL, SHE BOLUSED, AND AGAIN A FEW HOURS LATER 498 MG/DL. PATIENT STATED SHE BOLUSED AGAIN AND SEVERAL HOURS LATER HER BLOOD GLUCOSE LEVEL WAS 400 MG/DL. PATIENT REPORTED THAT ON THE NEXT MORNING SHE CHECKED HER BLOOD GLUCOSE LEVEL, IT WAS 393 MG/DL WHICH WAS STILL HIGH FOR HER. PATIENT STATED ON FRIDAY MORNING, THE MORNING HER BLOOD GLUCOSE LEVEL WAS 393 MG/DL, SHE FELT TIRED AND LIKE SHE COULD NOT GET UP AND WAS TAKEN TO THE ER AND THEN ADMITTED TO THE HOSPITAL WITH DKA AND ELEVATED BLOOD GLUCOSE LEVELS. PATIENT REPORTED SHE WAS TREATED FOR BOTH DKA AND ELEVATED BLOOD GLUCOSE LEVELS BUT DOES NOT KNOW THE DETAILS OF HER TREATMENT. PATIENT STATED HER BLOOD GLUCOSE LEVEL HAS NOW RETURNED TO NORMAL. PATIENT REPORTED HER LAST BLOOD GLUCOSE LEVEL WAS IN THE 100'S MG/DL. PATIENT IS STILL IN THE HOSPITAL. PATIENT REPORTED THAT WHILE IN THE HOSPITAL, SHE WAS TREATED FOR LOW BLOOD GLUCOSE AFTER HAVING BEEN REMOVED FROM THE INFUSION DEVICE; HER BLOOD GLUCOSE WENT DOWN TO 63 MG/DL AND WAS TREATED WITH APPLE JUICE. PATIENT STATED THE INFUSION DEVICE DID NOT DISPLAY AN ERROR OR ALERT. PATIENT REPORTED THAT WHILE SHE WAS IN THE HOSPITAL SHE LOOKED DOWN AT THE INFUSION DEVICE AND IT WAS ALL WET. PATIENT REPORTED IT WAS COVERED WITH A STICKY SUBSTANCE THAT SHE THOUGH MAY HAVE BEEN INSULIN. PATIENT STATED THE ENTIRE OUTSIDE OF THE INFUSION DEVICE WAS WET WITH THIS SUBSTANCE IN HER CASE AND THE CARTRIDGE COMPARTMENT WAS WET TOO. PATIENT REPORTED SHE HAD ENOUGH TO POUR THIS SUBSTANCE OUT; SHE THOUGHT IT MAY BE INSULIN. PATIENT STATED SHE THOUGHT THERE WAS A LEAK. PATIENT REPORTED SHE DOES HEAR AN AUDIBLE CLICK WHEN ATTACHING THE INFUSION SET TUBING TO THE HEADSET. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE, INFUSION SET, ADAPTER, AND INSULIN CARTRIDGE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201872 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 047 YR Hospitalization| O| R DEXCOM CONTINUOUS GLUCOSE MONITOR| HUMALOG