BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3080934 · Received April 26, 2013

    Report

    Report Number
    2183996-2013-00750
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 13, 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

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. RESULT 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 ALARM AND SOUND FUNCTIONS OF THE PUMP WAS TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 1

    THIS 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 A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED EXPERIENCING ERRATIC BLOOD GLUCOSE LEVELS OF 39-506 MG/DL FOR TWO WEEKS. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PATIENT STATED THE INFUSION DEVICE IS LOUDER FOR 1.5 MONTHS. PATIENT REPORTED SHE DOES NOT REACT CORRECTLY AND NEEDS ASSISTANCE FROM HER FAMILY: IF HER BLOOD GLUCOSE LEVEL IS TOO LOW, HER FAMILY STOPS THE INFUSION DEVICE AND GIVES HER A FAST CARBOHYDRATE, AND IF HER BLOOD GLUCOSE LEVEL IS TOO HIGH, HER FAMILY PROGRAMS THE CORRECTION BOLUS. PATIENT STATED SHE NOW THINKS THE INFUSION DEVICE DELIVERS INACCURATE INSULIN. NO FURTHER INFORMATION IS AVAILABLE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181215 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 030 YR Required Intervention HUMALOG