BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM II TEST STRIPS

    MDR report key: 3884172 · Received June 19, 2014

    Report

    Report Number
    1823260-2014-04474
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K121679
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH IDENTIFIER (B)(6) IS INFORM II SYSTEM 1, MEDWATCH WITH IDENTIFIER (B)(6) IS INFORM II SYSTEM 2. CALLER REPORTED INFORM II STRIP LOT WAS EITHER 471353 (EXPIRATION 11/30/2014) OR 471354 (EXPIRATION 12/31/2014), COULD NOT PROVIDE WHICH STRIP LOT WAS USED IN EITHER TEST, BUT KNOWS THE TWO LOTS ARE IN USE IN THE NURSERY. STRIPS WILL NOT BE RETURNED BECAUSE THE ORIGINAL VIAL(S) WERE USED UP. STRIPS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    CALLER REPORTED NEONATE BLOOD GLUCOSE RESULTS OF LO, WHICH ON THE SYSTEM INDICATES A RESULT OF LESS THAN 10 MG/DL, ON INFORM II SYSTEM 1, 40 MG/DL ON INFORM II SYSTEM 2 WITHIN 10 MINUTES. CALLER STATED THAT LAST WEEK, STAFF REPORTED THAT THIS METER HAD BLUE CONTROL FLUID IN THE STRIP PORT ALTHOUGH SHE DOES NOT SEE ANY BLUE FLUID OR DRIED RESIDUE IN THE PORT TODAY. NO ADVERSE EVENT WAS REPORTED. STRIPS ARE NOT AVAILABLE FOR RETURN. A REQUEST WAS MADE FOR THE RETURN OF THE METER, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359964 ACCU-CHEK ® INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1