BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM II TEST STRIPS

    MDR report key: 3782015 · Received April 30, 2014

    Report

    Report Number
    1823260-2014-03120
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 6, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K121679
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT AVAILABLE FOR RETURN.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH IDENTIFIER (B)(6) IS INFORM II (B)(4), MEDWATCH WITH IDENTIFIER (B)(6) IS INFORM II (B)(4).

    Description of Event or Problem · 1

    CALLER REPORTED (B)(6) 2014 INFORM II NEONATE RESULT OF 40 MG/DL ON METER SERIAL NUMBER (B)(4) AND 2 MINUTES LATER ON METER (B)(4) RESULT WAS 71 MG/DL. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260138 ACCU-CHEK ® INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 471357

    Patients

    Seq Age Sex Outcome Treatment
    1 001 DA