BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1980097 · Received February 7, 2011

    Report

    Report Number
    1823260-2011-00643
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 29, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    REPORTER ALLEGED OBTAINING THE RESULTS OF 141 MG/DL AND 30 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER STATED THAT SHE TOOK 54 UNITS OF LANTUS AS SHE NORMALLY WOULD AFTER THE 141 MG/DL RESULT. REPORTER STATED THAT SHE SELF-TREATED WITH A CAN OF COKE AND GLUCOSE TABLETS AFTER THE 30 MG/DL RESULT. 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 303015

    Patients

    Seq Age Sex Outcome Treatment
    1 069 YR OMEGA 3 (DAILY)| LORAZEPAM (THRICE WEEKLY)| NASONEX (DAILY)| VITAMIN E (DAILY)| LEVOCETIRIZINE (DAILY)| LANTUS (DAILY)| FUROSEMIDE (4 TIMES WEEKLY)| APIDRA (SLIDING SCALE)| NEXIUM (DAILY)| ASPIRIN (DAILY)| NASAL SALINE (AS NEEDED)| RESVERATROL PLUS (DAILY)| FISH OIL (DAILY)| DOCUSATE SODIUM (TWICE DAILY)| PROMETHAZINE (DAILY)| HYDROCORTISONE CREAM| ZYRTEC (DAILY)| SINGULAIR (DAILY)| RENVELA (5 TIMES DAILY)| LIPITOR (DAILY)| LOSARTAN (4 TIMES WEEKLY)| TRIAMCINOLONE ACETONIDE| NEPHRO-VITE (DAILY)| WHEELCHAIR