BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2982063 · Received February 8, 2013

    Report

    Report Number
    2183996-2013-00157
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 7, 2013
    Report Date
    April 15, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    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 ALARM FUNCTIONS OF THE PUMP WAS TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE BLUETOOTH FUNCTIONS OF THE PUMP WAS TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS.

    Description of Event or Problem · 1

    PT REPORTED THE INFUSION DEVICE HAS DELIVERED 25.0 UNITS OF INSULIN ON SEVERAL OCCASIONS THAT WAS NOT PROGRAMMED. THE 25.0 UNITS ARE DISPLAYED IN THE INFUSION DEVICE AND BLOOD GLUCOSE METER HISTORY; HOWEVER, HER BLOOD GLUCOSE HAS NOT BEEN AFFECTED. PT REPORTED SHE NEVER DELIVERS BOLUSES LARGER THAN 17.0 UNITS. ONE INSTANCE WAS CLOSE IN TIME TO AN INFUSION SET CHANGE AND ANOTHER TIME IS OCCURRED TWICE IN THE SAME DAY. PT REPORTED THIS IS NOT DUE TO PRIMING THE INFUSION SET. SHE IS CONCERNED HER DAUGHTER HAS PLAYED WITH THE INFUSION DEVICE, AND SHE FEELS THE INFUSION DEVICE IS UNSAFE. THE INFUSION DEVICE AND BLOOD GLUCOSE METER WERE REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND SHE DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55280 ACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN