BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT PLUS TEST DRUM

    MDR report key: 3912120 · Received July 3, 2014

    Report

    Report Number
    1823260-2014-04875
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    July 30, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH IDENTIFIER (B)(6) IS FOR COMPACT PLUS SYSTEM. MEDWATCH WITH IDENTIFIER (B)(6) IS FOR AVIVA SYSTEM.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 34 MG/DL ON COMPACT PLUS SYSTEM, 136 MG/DL ON AVIVA SYSTEM WITHIN 10 MINUTES. 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
    389370 ACCU-CHEK ® COMPACT PLUS TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20809256

    Patients

    Seq Age Sex Outcome Treatment
    1 086 YR SERTRALINE| ADVAIR| OMEPRAZOLE| LASIX| HYDRALAZINE| FISH OIL| SIMVASTATIN| ABOBART| PRESERVISION| PACEMAKER| CARVEDILOL| SPIRONOLACTONE| NOVOLOG| ISOSORBIDE