BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    MDR report key: 3539404 · Received December 27, 2013

    Report

    Report Number
    1823260-2013-07954
    Event Type
    Malfunction
    Date Received
    December 27, 2013
    Date of Event
    December 3, 2013
    Report Date
    January 2, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K113137
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH IDENTIFIER (B)(6) IS LOT 471505, MEDWATCH WITH IDENTIFIER (B)(6) IS LOT 471612.

    Description of Event or Problem · 1

    CALLER REPORTED NANO SYSTEM BLOOD GLUCOSE RESULTS, ALL MG/DL: 433, 10:50 PM, (B)(6) 2013; 384, 10:51 PM, (B)(6) 2013; 548, 10:52 PM, (B)(6) 2013; 356, 10:53 PM, (B)(6) 2013; 241, 10:55 PM, (B)(6) 2013. TWO VIAL OF STRIPS, LOTS 471505 AND 471612, WERE USED DURING COMPARISON. SHE RAN OUT OF 471505 AND BEGAN USING 471612. SHE DOES NOT REMEMBER AT WHAT POINT SHE CHANGED STRIPS DURING THE SUCCESSION OF READINGS THAT SHE TOOK. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676823 ACCU-CHEK ® SMARTVIEW TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 471612

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR BLOOD PRESSURE MONITOR| HYDROCHLOROTHIAZIDE 1XDAY| HUMULIN R SLIDING SCALE| HUMULIN N| GABAPENTIN| CLONIDINE| SIMVASTATIN 1XDAY