BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    MDR report key: 3160176 · Received June 10, 2013

    Report

    Report Number
    1823260-2013-03488
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 3, 2013
    Report Date
    July 19, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K113137
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 AN INCIDENT OF HYPERGLYCEMIA REQUIRING HOSPITALIZATION. THE CUSTOMER STATES THAT HIS NANO SYSTEM BLOOD GLUCOSE RESULTS FOR THE TWO WEEKS PRIOR TO THE HOSPITALIZATION WERE IN THE 100-150 MG/DL RANGE, HIS USUAL RANGE. FOR THIS REASON HE HAD NOT TAKEN HIS INSULIN FOR TWO WEEKS PRIOR TO THE HOSPITALIZATION EVEN THOUGH HE REPORTED A HYPERGLYCEMIC SYMPTOM OF LETHARGY TWO WEEKS PRIOR TO HIS HOSPITALIZATION. AT APPROXIMATELY 14.30 ON THE DAY OF ADMISSION HIS BLOOD GLUCOSE RESULT WAS 124 MG/DL. HE REPORTED THE HYPERGLYCEMIC SYMPTOM OF LETHARGY. IT IS NOT ENTIRELY CLEAR FROM HIS STATEMENTS WHETHER OR NOT THE LETHARGY HE REPORTED BEGINNING TWO WEEKS PRIOR TO HIS HOSPITALIZATION WAS CONTINUOUS OR INTERMITTENT. AT APPROXIMATELY 17.00 HE BEGAN TO VOMIT BLOOD. THE EMTS ARRIVED AT ABOUT 17.20. HE WAS TRANSPORTED TO THE HOSPITAL BY AMBULANCE WITHOUT ANY GLUCOSE VALUES OR TREATMENTS. AT APPROXIMATELY 18.00 HIS GLUCOSE VALUE AT THE HOSPITAL WAS 624 MG/DL AND HE WAS GIVEN INSULIN INTRAVENOUSLY. HIS HOSPITALIZATION WAS DESCRIBED INITIALLY AS FROM (B)(6) 2013 AND LATER CORRECTED TO FROM (B)(6) 2013. 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
    260399 ACCU-CHEK ® SMARTVIEW TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 044 YR Hospitalization VICODIN| COZAAR| LIPITOR| ERYTHROMYCIN| HUMALIN R| HUMALIN N| PROSTECTIC LEG| WARFARIN| GABAPENTIN| WHEEL CHAIR