BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1930752 · Received December 16, 2010

    Report

    Report Number
    1823260-2010-07523
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    December 9, 2010
    Report Date
    January 26, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THE CUSTOMER RECEIVED A RESULT OF 55 MG/DL ON THE AVIVA SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 585 MG/DL ON THE HOSPITAL SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER STATED THAT SHE TOOK THE CUSTOMER TO THE HOSPITAL BECAUSE SHE HAD SLURRED SPEECH, DRY MOUTH, WAS WEAK AND LETHARGIC. REPORTER STATED THAT THE CUSTOMER WAS PUT ON IV FLUIDS AND INSULIN. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. 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 303016

    Patients

    Seq Age Sex Outcome Treatment
    1 077 YR Hospitalization| R SYNTHROID| MULTIVITAMIN| HEART MEDICINE- UNKNOWN TYPE| LANTUS| PLAVIX| CALCIUM