BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2231430 · Received September 1, 2011

    Report

    Report Number
    1823260-2011-04694
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 6, 2011
    Report Date
    October 3, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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.

    Description of Event or Problem · 1

    CALLER REPORTED AN INCIDENT OF HYPOGLYCEMIA REQUIRING PROFESSIONAL MEDICAL TREATMENT AT A TIME WHEN THE AVIVA METER WAS UNAVAILABLE FOR USE DUE TO ERROR WITHIN SPECIFICATIONS. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 303237

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR Required Intervention ALLOPURINOL| GABAPENTIN| DILTIAZEM| GLIPIZIDE 1XDAY| HCTZ| LISINOPRIL| METOPROLOL| TRAVATAN