BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2890722 · Received December 21, 2012

    Report

    Report Number
    2183996-2012-02039
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 15, 2012
    Report Date
    March 26, 2013
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED FOR EVALUATION ON (B)(4) 2013. THE COMPLAINT CANNOT BE VERIFIED. THE PRODUCT MEETS THE SPECIFICATIONS REGARDING THE CUSTOMER'S ALLEGATION. THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. THE ADAPTER AND BATTERY COVER PASSED THE OPTICAL INSPECTION. THE RETURNED USED HEADSET AND THE TWO USED TRANSFER SETS WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. ONE OF THE TWO TRANSFER SETS WAS OCCLUDED AT THE CONNECTOR NEEDLE WITH INSULIN. THE HEADSET TEST RESULTS WERE WITHIN SPECIFICATIONS. THE RECEIVED USED CARTRIDGE WAS VISUALLY, LEAK, AND GLIDE FORCE TESTED. CARTRIDGE PASSED THE VISUAL TEST AND THE LEAKAGE TEST AT DIFFERENT POSITIONS OF THE PLUNGER ROD. THE GLIDE FORCE MEASURED IS IN ACCORDANCE WITH PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT REPORTED SHE HAD BEEN IN THE HOSPITAL WITH BLOOD GLUCOSE LEVELS OF 510 MG/DL. HER NORMAL RANGE IS 100-200 MG/DL. WHEN THE PATIENT WENT TO BED ON (B)(6) 2012, HER BLOOD GLUCOSE LEVEL WAS 120 MG/DL AND THE NEXT MORNING IT WAS 510 MG/DL. SHE STATED THAT THE EMT'S WERE CALLED AND THAT SHE HAD KETONES AT HOME AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS AT THE HOSPITAL. SHE WAS TREATED WITH AN IV OF INSULIN. SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012 AND WAS THERE FOR 24 HOURS. SHE WAS PUT IN THE INTENSIVE CARE UNIT FOR OBSERVATION. SHE STATED THAT HER BLOOD GLUCOSE LEVELS HAD BEEN ELEVATED FOR THE PAST 30 DAYS. ON (B)(6) 2012, SHE NOTICED AIR BUBBLES IN THE INFUSION TUBING. SHE PRIMES THE AIR BUBBLES OUT OF THE TUBING WHEN CHANGING ACCESSORIES, BUT SHE SAYS THEY APPEAR AFTER THAT. THE PATIENT FELT WETNESS AT THE LUER LOCK ON THE INFUSION SET. SHE DOES HEAR AN AUDIBLE CLICK WHEN ATTACHING THE INFUSION TUBING. THE PATIENT SWITCHED TO HER BACKUP INFUSION DEVICE AND HER BLOOD GLUCOSE LEVELS RETURNED TO NORMAL. THE INFUSION DEVICE WAS REPLACED. THE INFUSION SET, INSULIN CARTRIDGE, INFUSION DEVICE, AND ADAPTER WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R RELATED ACCESSORIES| INSULIN| DATES OF THERAPY: UNK| INSULIN INFUSION PUMP