BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 3122645 · Received May 21, 2013

    Report

    Report Number
    1823260-2013-03084
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER STATES THAT THE FOLLOWING READINGS WERE ALLEGEDLY RECEIVED ON A PATIENT USING THE INFORM METER, COMPARED TO LAB READINGS, WITHIN 10 MINUTES: 1. HI (GREATER THAN 600 MG/DL) (INFORM) AND 200 MG/DL (LAB) 2. HI (GREATER THAN 600 MG/DL) (INFORM) AND 180-200'S MG/DL (LAB) SETS OF READINGS WERE TAKEN AT DIFFERENT TIMES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. CALLER STATES THAT CONTROLS WERE RUN AND PASSED PRIOR TO THE INCIDENT; HOWEVER, ACTUAL RESULTS WERE NOT PROVIDED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223874 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551870

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR FOLEY CATHETER| LIPITOR 1X DAILY| CITRATE AND VITAMIN D 1X DAILY| ASPIRIN 1X DAILY| NOVOLIN N 2X DAILY| LISINOPRIL 1X DAILY| MULTIVITAMIN WITH MINERALS 1X DAILY| ULTICARE 3X DAILY| NOVOLOG| HARRINGTON ROD PLACEMENT| G-TUBE