BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2011774 · Received March 9, 2011

    Report

    Report Number
    1823260-2011-01270
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1. REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 2.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 80 MG/DL ON COMPACT PLUS SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 144 MG/DL ON COMPACT PLUS SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER STATED THAT HE TOOK UNSPECIFIED DIABETIC MEDICATION 1.5 HOURS PRIOR TO OBTAINING THE READINGS. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20728944

    Patients

    Seq Age Sex Outcome Treatment
    1 070 YR NOVOLOG| FUROSEMIDE| KLOR-CON| ASPIRIN| SIMVASTATIN| AMLODIPINE BESYLATE| METOPROLOL| LISINOPRIL| LANTUS| DOXAZOSIN MESYLATE