BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3243610 · Received July 23, 2013

    Report

    Report Number
    2183996-2013-01366
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 31, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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.

    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. HISTORY LIST: THE DESCRIBED EVENT THAT THE PUMP DELIVER SEVERAL BOLUS IN ROW IS REPEATEDLY IN THE PUMP HISTORY, EG, ON (B)(6) 2013 AT 18:19. THE BOLUS IN ROW ARE ALWAYS PROGRAMMED ON PUMP. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    PATIENT'S DOCTOR REPORTED SHE HAD DOWNLOADED DATA FROM THE PATIENT'S INFUSION DEVICE AND METER AND THAT SHE COULD SEE THAT SEVERAL TIMES IT APPEARED ON THE DOWNLOAD THAT THE INFUSION DEVICE HAD DELIVERED 3 BOLUSES OF 25 UNITS OF INSULIN IN A ROW; FOR EXAMPLE 25 UNIT BOLUS NOT FOR CARB CORRECTION WAS GIVEN, THEN IT WAS REPEATED TWICE. DOCTOR STATED THAT WHEN SHE OBSERVED THIS SHE ASSUMED IT MUST BE AN ERROR WITH THE SOFTWARE. DOCTOR REPORTED SHE ATTEMPTED TO CONTACT A COMPANY REPRESENTATIVE WITHOUT SUCCESS AND CALLED BACK. DOCTOR STATED THE BOLUS HAD BEEN REPEATED 3 TIMES IN THE MY DATA OF THE PUMP AND ALSO ON THE METER. DOCTOR REPORTED THAT THE PATIENT WOULD HAVE ONLY BOLUSED VIA THE METER. DOCTOR STATED THAT SHE COULD SEE ON THE DOWNLOAD AND ON THE INFUSION DEVICE THAT THE 3 BOLUSES HAD BEEN DELIVERED AND THEY WERE DEFINITELY NOT FOR CARBS. DOCTOR REPORTED THE PATIENT IS COMPETENT AND THAT IN HER OPINION THIS IS NOT USER ERROR. DOCTOR REQUESTED A REPRESENTATIVE LOOK AT THE INFUSION DEVICE, METER AND THE DOWNLOAD. DOCTOR STATED SHE HAD GIVEN THE PATIENT ANOTHER INFUSION DEVICE WHILE SHE LOOKED INTO THIS CONCERN. REQUEST FOR ASSISTANCE WAS SUBMITTED; REPRESENTATIVE IS WORKING DIRECTLY WITH THE DOCTOR. REPRESENTATIVE (NURSE) REPORTED SHE COULD NOT SEE ANY DRAMATIC PATTERNS IN THE PATIENT'S BLOOD GLUCOSE LEVELS. REPRESENTATIVE STATED THE DOCTOR HAD REPORTED THIS CONCERN TO THE LOCAL AUTHORITIES. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE INFUSION DEVICE AND THE METER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342469 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1