BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT PLUS TEST DRUM

    MDR report key: 3877012 · Received June 17, 2014

    Report

    Report Number
    1823260-2014-04413
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 19, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 REPORTED COMPACT PLUS SYSTEM BLOOD GLUCOSE RESULTS: 28 MG/DL AT 0503 100 MG/DL AT 0509 26 MG/DL AT 0557 127 MG/DL AT 0558 NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Description of Event or Problem · 1

    CALLER REPORTED COMPACT PLUS SYSTEM BLOOD GLUCOSE RESULTS: 28 MG/DL AT 0503; 100 MG/DL AT 0509; 26 MG/DL AT 0557; 127 MG/DL AT 0558. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT. ON (B)(6) 2014, THE FOLLOWING INFORMATION WAS DETERMINED: COMPARISON FOUND ABOVE: 28 MG/DL AT 0503; 100 MG/DL AT 0509 WAS DETERMINED TO BE 26 MG/DL, NOT 28 MG/DL. ON (B)(6)- 23 MG/DL AND 116 MG/DL WITHIN 10 MINUTES. ON (B)(6)- 17 MG/DL, 21 MG/DL, AND 100 MG/DL WITHIN 10 MINUTES. ON (B)(6)- 14 MG/DL AND 105 MG/DL WITHIN 10 MINUTES. ON (B)(6)- 18 MG/DL AND 89 MG/DL. ON (B)(6)- 26 MG/DL AND 100 MG/DL WITHIN 10 MINUTES. ON (B)(6)- 19 MG/DL, 22 MG/DL, AND 14 MG/DL 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
    354010 ACCU-CHEK ® COMPACT PLUS TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20809253

    Patients

    Seq Age Sex Outcome Treatment
    1 082 YR ACIDOPHILUS| B-6| LISINOPRIL| WALKER| CANE| GLIPIZIDE| GARLIC| METFORMIN