BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3033838 · Received April 3, 2013

    Report

    Report Number
    1823260-2013-02053
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 11, 2013
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH IDENTIFIER (B)(6) IS AVIVA SYSTEM 1, MEDWATCH WITH IDENTIFIER (B)(6) IS AVIVA SYSTEM 2.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH IDENTIFIER (B)(6) IS AVIVA SYSTEM 1, MEDWATCH WITH IDENTIFIER (B)(6) IS AVIVA SYSTEM 2. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE USED STRIPS WERE RETURNED.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS ON AVIVA SYSTEM 1: 3:07 AM 26 MG/DL 3:09 AM LO, WHICH ON THE SYSTEM INDICATES A RESULT LESS THAN 20 MG/DL BLOOD GLUCOSE RESULTS ON AVIVA SYSTEM 2: 3:18 AM 221 MG/DL 3:19 AM 230 MG/DL 3:20 AM 275 MG/DL NO ADVERSE EVENT WAS REPORTED. AVIVA SYSTEM 1 STRIPS ARE NOT AVAILABLE FOR RETURN, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136998 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491600

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female AMLODIPINE BESYLATE| BLOOD PRESSURE CUFF| CALCIUM| LEVEMIR| LISINOPRIL| NOVOLOG INSULIN| OMEGA 3 FISH OIL TABLET| ONGLYZA| SIMVASTATIN| VIT C, B-12 AND E 1XDAY| SIMVASTATIN| VIT C, B-12 AND E 1XDAY| CALCIUM| BLOOD PRESSURE CUFF| AMLODIPINE BESYLATE| LEVEMIR| ONGLYZA| NOVOLOG INSULIN| LISINOPRIL| OMEGA 3 FISH OIL TABLET