BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3014194 · Received March 21, 2013

    Report

    Report Number
    2183996-2013-00468
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    January 14, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CAN BE VERIFIED. BASED ON THE HISTORY ANALYSIS, THE PUMP HAD HIGH POWER CONSUMPTION. A DEFECTIVE COMPONENT IN THE POWER SUPPLY PATH LED TO A LEAKAGE CURRENT; THEREFORE, A BATTERY CHANGE HAD TO BE PERFORMED FREQUENTLY. DUE TO A QUICK DISCHARGE OF THE BATTERY, THE W2 "BATTERY LOW WARNING" DID NOT ALERT THE USER BUT THE E2 "BATTERY EMPTY ERROR" OCCURRED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED THE INFUSION DEVICE HAS HAD HIGH POWER CONSUMPTION AND DOES NOT PROPERLY PROVIDE THE W2 BATTERY LOW WARNING BEFORE THE E2 BATTERY EMPTY ERROR. THIS WAS VERIFIED IN THE INFUSION DEVICE HISTORY. THE ALKALINE BATTERY IN USE WAS NOT EXPIRED. THE BATTERY AND BATTERY COVER WERE USED WITHIN SPECIFICATION, AND THE AVERAGE BATTERY LIFE HAS BEEN LESS THAN 5 DAYS. THE BATTERY CONTACTS ARE NOT DAMAGED. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND HE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE, BATTERY, AND BATTERY COVER WERE REPLACED AND REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117524 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR HUMALOG| ACCU-CHEK AVIVA COMBO