BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2517218 · Received April 4, 2012

    Report

    Report Number
    1823260-2012-01795
    Event Type
    Malfunction
    Date Received
    April 4, 2012
    Date of Event
    March 17, 2012
    Report Date
    April 9, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    REPORTER ALLEGED THAT THE CUSTOMER OBTAINED A RESULT OF 106 MG/DL ON THE AVIVA SYSTEM WHILE HAVING HYPOGLYCEMIC SYMPTOMS. REPORTER STATED THAT HE RUBBED SUGAR (1 (B)(4)) IN HER MOUTH TO DISSOLVE AND THEN SHE DRANK A 16 OZ (B)(4). 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 ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 303490

    Patients

    Seq Age Sex Outcome Treatment
    1 046 YR HUMALOG| LANTUS