BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3082098 · Received April 29, 2013

    Report

    Report Number
    2183996-2013-00753
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 26, 2013
    Report Date
    July 29, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    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 TECHNICAL INVESTIGATION OF THE PUMP SHOWED THAT THE CARTRIDGE VOLUME ADJUSTMENT WAS NOT CONFIRMED AFTER THE REWIND ON (B)(6) 2013. THIS LED TO A MENU TIMEOUT. THIS IS THE LAST EVENT WHEN THE PUMP WAS IN USE AND THE PUMP WAS IN STOP. 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'S FATHER REPORTED THE PISTON ROD ON THE INFUSION DEVICE WOULD NOT REWIND. FATHER STATED HE CHANGED THE BATTERY AND THE PISTON ROD BEGAN TO REWIND AGAIN; THE REWIND WORKS FINE. FATHER REPORTED AFTER THIS ISSUE, THE PATIENT'S BLOOD GLUCOSE LEVEL BECAME ELEVATED WITH THE HIGHEST LEVEL UP TO 320 MG/DL. FATHER STATED HE THINKS THE INFUSION DEVICE DELIVERS TOO LOW INSULIN. FATHER REPORTED HE CHANGED THE INFUSION DEVICE TO THE BACKUP INFUSION DEVICE FOR HIS DAUGHTER. FATHER STATED AFTER CHANGING THE INFUSION DEVICE THE PATIENT'S BLOOD GLUCOSE LEVEL RETURNED TO NORMAL LEVEL. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. NO OUTSIDE ASSISTANCE WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185837 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1