BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3030114 · Received April 2, 2013

    Report

    Report Number
    2183996-2013-00545
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 19, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    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 OCCLUSION LIMITS WERE TESTED SUCCESSFULLY. DURING THE INVESTIGATION OF THE RETURNED METER, THE IU DID NOT OBSERVE THE METER DELIVERING RANDOM BOLUSES TO THE RETENTION PUMP. 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. A VISUAL INSPECTION AND TESTS FOR FLOW AND LEAK WERE PERFORMED ON THE RETURNED USED INFUSION SET, AND ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED REGARDING THIS COMPLAINT. PATIENT REPORTED SHE EXPERIENCED A SEIZURE DURING THE (B)(6) OF 2012 WHILE WITH AN EMERGENCY DOCTOR. PATIENT HAD CORRECTED HYPERGLYCEMIA AND AFTERWARDS EXPERIENCED HYPOGLYCEMIA. SHE ATE DEXTROSE AS TREATMENT. SHE BELIEVES THE CAUSE OF THIS EVENT WAS DUE TO DELAYED DISPLAY OF AN E4 OCCLUSION ERROR.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INFUSION DEVICE DELIVERED UNINTENDED INSULIN AND THIS RESULTED IN SEVERE HYPOGLYCEMIA. SHE ATE 3.5 BE AND DRANK .03 CL OF WINE ON (B)(6) 2013, AT 9:13 P.M., AND SHE DELIVERED 3 I.U. OF INSULIN VIA THE INFUSION DEVICE. HER HUSBAND, WHO IS A DIABETES SPECIALIST, FOUND HER UNCONSCIOUS AT 10:10 P.M. HE ADMINISTERED A GLUCAGON INJECTION, AND HER BLOOD GLUCOSE MEASURED 50 MG/DL (TIME UNKNOWN). HUSBAND CHECKED THE BLOOD GLUCOSE METER/REMOTE HISTORY AND DETECTED 2 BOLUSES OF 3 I.U. WERE STORED AT 9:40 P.M. AND 9:44 P.M. ON (B)(4) 2013, AT 7:00 P.M., SHE ATE 4.5 BE AND DELIVERED 2.9 I.U. VIA THE INFUSION DEVICE. HER BLOOD GLUCOSE LEVEL WAS 61 MG/DL AT 8:18 P.M. AND SHE ATE 1 BE. HER BLOOD GLUCOSE WAS 43 MG/DL AT 8:55 P.M. AND SHE ATE 15 BE. HER BLOOD GLUCOSE WAS 43 MG/DL AT 9:30 P.M. AND 117 MG/DL AT 10:00 P.M. SHE STOPPED INFUSION DEVICE THERAPY AT THAT TIME. SHE ALSO REPORTED THE INFUSION DEVICE DOES NOT CORRECTLY PROVIDE E4 OCCLUSION ERRORS. SHE STARTED USING A REPLACEMENT INFUSION DEVICE ON (B)(6) 2013 AND HAS EXPERIENCED NO FURTHER PROBLEMS. THE INFUSION DEVICE AND BLOOD GLUCOSE METER WERE REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133988 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 047 YR Required Intervention HUMALOG