BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2871426 · Received December 5, 2012

    Report

    Report Number
    2183996-2012-01911
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 27, 2012
    Report Date
    March 11, 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
    IA, 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 SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. THE DELIVERY ACCURACY AND THE OCCLUSION LIMITS WERE TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. NOTHING UNUSUAL WAS FOUND IN THE PUMP HISTORY. THE ADAPTER AND BATTERY COVER PASSED THE OPTICAL INSPECTION. THE RECEIVED USED CARTRIDGE WAS VISUALLY, LEAK AND GLIDE FORCE TESTED. THE CARTRIDGE PASSED THE VISUAL TEST AND THE LEAKAGE TEST AT DIFFERENT POSITIONS OF THE PLUNGER ROD, AND THE GLIDE FORCE MEASURED IS IN ACCORDANCE WITH PRODUCT SPECIFICATIONS. THE INFUSION SET SAMPLE WAS VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. THE TEST RESULTS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, PT REPORTED THE INFUSION DEVICE IS NOT CORRECTLY STORING AND DELIVERING THE BASAL RATES AND SHE EXPERIENCED A SEVERE HYPOGLYCEMIC EPISODE. HER HUSBAND FOUND HER UNCONSCIOUS ON (B)(6) 2012 AND CONTACTED THE PARAMEDICS. PARAMEDICS STARTED 2 IVS, AND ONE CONTAINED DEXTROSE. HER BLOOD GLUCOSE WAS 33 MG/DL AT THE EMERGENCY ROOM, AND SHE REC'D TREATMENT BUT WAS NOT ADMITTED. SHE HAD EXPERIENCED HYPOGLYCEMIA FOR A WEEK PRIOR, AND SHE REPORTED SHE IS "BRITTLE" AND DOES NOT HAVE A NORMAL RANGE. SHE DOES NOT FEEL SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE. HOSPITAL ADVISED HER TO DECREASE THE BASAL RATES IN THE INFUSION DEVICE. SHE DID THIS AND REPORTED THE INFUSION DEVICE REVERTED TO THE PREVIOUS RATES. THE CARTRIDGE AND INFUSION SET WERE CHANGED ON (B)(6) 2012. SHE HAD NO RECENT CHANGES TO DIET, EXERCISE, OR LIFESTYLE. PT SWITCHED TO HER BACKUP INFUSION DEVICE, AND THE ALLEGED INFUSION DEVICE, INFUSION SET, CARTRIDGE, AND ADAPTER WERE REQUESTED FOR EVAL. F/U WAS COMPLETED ON (B)(6) 2012, AND SHE REPORTED HER BLOOD GLUCOSE WAS "HOLDING NICELY" ON THE BACKUP INFUSION DEVICE.

    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
    1 067 YR Hospitalization| R RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP