BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2959016 · Received February 8, 2013

    Report

    Report Number
    2183996-2013-00185
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION 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 PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF 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.

    Description of Event or Problem · 1

    PATIENT'S DIABETES NURSE REPORTED ON (B)(6) 2013 AT 12 PM THE INFUSION DEVICE WAS CONNECTED TO THE PATIENT WITH A BLOOD GLUCOSE VALUE OF 20.4 MMOL/L (367 MG/DL). NURSE STATED AT 6 PM THE PATIENT MEASURED HER BLOOD GLUCOSE LEVEL AT 1.2 MMOL/L (22 MG/DL) AND CONTACTED HER DOCTOR. NURSE REPORTED THE PATIENT'S DOCTOR GAVE HER GLUCAGON AND HER BLOOD GLUCOSE LEVEL ROSE TO 7.0 MMOL/L (126 MG/DL). NURSE STATED AT NIGHT THE PATIENT'S HUSBAND MEASURED HER BLOOD GLUCOSE LEVEL AT 1.2 MMOL/L (22 MG/DL) AGAIN AND THE DOCTOR WAS NOTIFIED AGAIN. NURSE STATED GLUCAGON WAS ADMINISTERED AND 50% GLUCOSE. NURSE REPORTED THE PATIENT'S HUSBAND REMOVED THE INFUSION DEVICE AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA AMBULANCE WITH A LOW BLOOD GLUCOSE LEVEL OF 1.2 MMOL/L (22 MG/DL). PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. NURSE STATED PATIENT'S HUSBAND CALLED THE HOSPITAL BECAUSE SHE PASSED OUT. PATIENT REMAINED IN THE HOSPITAL FOR ONE NIGHT. NURSE REPORTED PATIENT IS HAVING VISION CONCERNS AND HER EYE SIGHT IS VERY BAD. NURSE STATED THE INSTRUCTOR INSTALLED THE BASAL RATE INTO THE INFUSION DEVICE. NURSE REPORTED SHE ASKED THE PATIENT HER BASAL RATE AND PATIENT INFORMED HER THE RATE HAD TO BE FOR 24 HOURS AT 4.0 UNIT/HOUR. NURSE STATED THE OTHER INSTRUCTOR WHO HAD PLACED THE CORRECT BASAL RATE IN THE LOANER INFUSION DEVICE AND ASSISTED THE PATIENT WITH CHANGING HER INFUSION DEVICE WITH THE LOANER INFUSION DEVICE. NO FURTHER INFORMATION IS AVAILABLE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53382 ACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| O| R RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN