BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM II TEST STRIPS

    MDR report key: 5192262 · Received October 30, 2015

    Report

    Report Number
    1823260-2015-04421
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 3, 2015
    Report Date
    October 30, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K121679
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. REFER TO THE MEDWATCH WITH (B)(6) FOR THE OTHER COMPLAINT POSSIBLY USING THIS VIAL OF STRIPS.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE BLOOD GLUCOSE RESULTS FROM AN ACCU- CHEK INFORM II METER. ON (B)(6) 2015 AT 3:55PM, THE RESULT WAS 385 MG/DL. LIKE WHAT? AT 4:02PM, THE RESULT WAS 164 MG/DL. AT 4:04PM, THE RESULT WAS 181 MG/DL. NO TREATMENT OR SERIOUS INJURY OCCURRED. TWO VIALS OF STRIPS OF THE SAME LOT NUMBER WERE USED FOR THIS COMPLAINT AND ANOTHER COMPLAINT USING THE SAME METER. IT WAS UNKNOWN WHICH VIAL OF STRIPS WAS USED FOR WHICH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722677 ACCU-CHEK ® INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 473389

    Patients

    Seq Age Sex Outcome Treatment
    1