BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    MDR report key: 3834582 · Received May 28, 2014

    Report

    Report Number
    1823260-2014-03739
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K113137
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER IS AT THE HOSPITAL FOR ROUTINE OUTPATIENT PROCEDURE. CALLER STATED THIS MORNING AT 8:02AM, HER NANO SYSTEM BLOOD GLUCOSE READING WAS 206 MG/DL. CALLER STATED THE HOSPITAL TOOK A READING AT 8:10AM WITH A RESULT OF 84 MG/DL. CALLER STATED SHE DRANK A CAN OF SODA AFTER THE HOSPITAL'S READING. CALLER STATED SHE DID ANOTHER READING ON HER METER AT 8:17AM WITH RESULT OF 106 MG/DL. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313844 ACCU-CHEK ® SMARTVIEW TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 472733

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR HUMALOG