BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2932176 · Received January 18, 2013

    Report

    Report Number
    2183996-2013-00064
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 13, 2013
    Report Date
    March 27, 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
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    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.

    Description of Event or Problem · 1

    PT REPORTED THE INSULIN DELIVERY OF THE INFUSION DEVICE IS TOO LOW. HIS BLOOD GLUCOSE WAS 150 MG/DL IN THE MORNING ON (B)(6) 2013, AND HE BOLUSED 15 IE FOR BREAKFAST USING HE METER REMOTE. HIS BLOOD GLUCOSE WAS 230 MG/DL AT 12:00 PM, AND HE BOLUSED 10 IE AS A CORRECTION USING THE METER REMOTE. HE DID NOT EAT LUNCH. HIS BLOOD GLUCOSE WAS 260 MG/DL AT 3:00 PM, AND HE BOLUSED 8 IE AS A CORRECTION USING THE METER REMOTE. HIS BLOOD GLUCOSE WAS 330 MG/DL AT 4:15 OM, AND HE BOLUSED 2 IE DIRECTLY FROM THE INFUSION DEVICE. THE 2 IE BOLUS IS NOT LISTED IN THE INFUSION DEVICE HISTORY. HE ALSO CHANGED THE INFUSION HEADSET THREE TIMES DURING THE DAY. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28587 ACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS, INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR INSULIN INFUSION PUMP| INSULIN| RELATED ACCESSORIES