BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3082649 · Received April 29, 2013

    Report

    Report Number
    2183996-2013-00755
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 23, 2013
    Report Date
    June 20, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED. THE PRODUCT MEETS THE SPECIFICATIONS REGARDING THE CUSTOMER'S ALLEGATION. ALL ALARM FUNCTIONS WERE TESTED SUCCESSFULLY AND NO MALFUNCTION WAS OBSERVED DURING THE TECHNICAL INVESTIGATION. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. E2 AND A2 ERRORS WERE FOUND IN THE HISTORY LIST, AND BEFORE EACH E2 OCCURRED THE PUMP CORRECTLY TRIGGERED AN A2 ALERT. THE BATTERY COVER PASSED THE OPTICAL INSPECTION.

    Additional Manufacturer Narrative · 1

    IT IS 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 DID NOT PROPERLY PROVIDE AN A2 BATTERY LOW ALERT BEFORE THE E2 BATTERY DEPLETED ERROR. THIS WAS VERIFIED BY VIEWING THE ALARM HISTORY. THE INFUSION DEVICE WAS NOT DROPPED ON A HARD SURFACE WITHIN THE PAST 48 HOURS. THE INFUSION DEVICE, BATTERY, AND BATTERY COVER WERE REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND 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
    185053 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 059 YR WHEELCHAIR| AVIVA METER| SCOOTER| NOVOLOG INSULIN (PUMP)| VITAMIN D3| OXYGEN| OXYGEN TANK| WALKER