BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3001173 · Received March 13, 2013

    Report

    Report Number
    2183996-2013-00382
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    March 1, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    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 ALARM FUNCTIONS OF THE INSULIN PUMP WERE TESTED WITHIN THE ALARM FUNCTIONS TEST 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. ALL ERRORS AND ALERTS ARE TRIGGERED CORRECTLY BY THE PUMP.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED THE INFUSION DEVICE DELIVERED 2 UNITS OF INSULIN WITHOUT BEING PROGRAMMED TO DO SO. THIS OCCURRED ON (B)(6) 2013 AROUND 11 P.M. SHE WAS AWAKE AND DID NOT EXPERIENCE ANY PHYSIOLOGICAL EFFECTS. SHE SWITCHED TO HER BACKUP INFUSION DEVICE, AND THE ALLEGED INFUSION DEVICE WAS REQUESTED FOR EVALUATION. SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104695 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR NOVALOG