BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 5367590 · Received January 14, 2016

    Report

    Report Number
    1823260-2016-00049
    Event Type
    Malfunction
    Date Received
    January 14, 2016
    Date of Event
    December 16, 2015
    Report Date
    February 4, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED 1 VIAL OF ACCU-CHEK INFORM II STRIPS (LOT 473514 WITH AN EXPIRATION OF 03/2016). 33 STRIPS WERE RETURNED. THE CUSTOMER ALSO RETURNED THE ACCUCHEK INFORM II METER (SERIAL NUMBER (B)(4)). THE INVESTIGATION DETERMINED THAT THE RETURNED STRIPS AND METER WORKED AS INTENDED. THE CUSTOMER ALLEGATION OF QUESTIONABLE RESULTS AS TESTED WITH RETURNED PRODUCTS IS NOT SUBSTANTIATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING RESULTS ON A PATIENT THAT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. THE SAME VIAL OF BLOOD GLUCOSE STRIPS WAS USED FOR THE TESTS PERFORMED ON THE INFORM II AND THE PERFORMA METERS. AT 1734 A CAPILLARY BLOOD GLUCOSE RESULT OF 193 MG/DL WAS OBTAINED ON THE ACCUCHEK PERFORMA METER (SERIAL NUMBER (B)(4)). AT 1742 A SAMPLE FROM A HEPARIN TUBE WAS DONE ON A BLOOD GAS ANALYZER AND RESULTED OUT A BLOOD GLUCOSE OF 34 MG/DL. AT 1752 A CAPILLARY BLOOD GLUCOSE RESULT OF 180 MG/DL WAS OBTAINED ON THE ACCUCHEK INFORM II (SERIAL NUMBER (B)(4)). AT 1754 THE BLOOD GLUCOSE RESULT OF 161 MG/DL WAS OBTAINED ON THE ACCUCHEK INFORM II. AT 1807 IT WAS REPORTED THAT "DEXTRO 50% 2CC, IVS" WAS GIVEN. AT 1817 THE BLOOD GLUCOSE RESULT OF 26 MG/DL WAS REPORTED AND IT WAS STATED THE SAMPLE WAS IN AN "SST TUBE / SAME BLOOD AS THE BLOOD GAS ANALYZER, BUT THE RESULTS CAME OUT AFTER 35 MINUTES". AT 1824 A CAPILLARY BLOOD GLUCOSE OF 235 MG/DL WAS OBTAINED ON THE ACCUCHEK INFORM II. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, ALTHOUGH THE DATE OF THE DISCHARGE WAS NOT REPORTED. THE SUSPECT DEVICE WAS REQUESTED TO BE RETURNED AND THE REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25146 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 473514

    Patients

    Seq Age Sex Outcome Treatment
    1