BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2920109 · Received January 17, 2013

    Report

    Report Number
    1823260-2013-00318
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 30, 2012
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE USED STRIPS WERE RETURNED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 64 MG/DL ON COMPACT PLUS SYSTEM, 34 MG/DL ON AVIVA COMBO SYSTEM WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26444 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491359

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male ACETAMINOPHEN| ASPRIN| B12 TABLET| DOCUSATE SODIUM TWICE A DAY| FISH OIL| FLUOXETINE 1XDAY| FOLIC ACID| HTC (BLOOD PRESSURE MEDICINE)| IPRATROPIUM BROMIDE| ISOSORBIDE 2 TIMES A DAY| LASIX 2 TIMES A DAY| LORATADINE| MAGNESIUM OXIDE| METHOTRIXATE| MUCINEX| MULTIVITAMIN| NEUPRO PATCH| NIACIN| NOVOLOG U100 INSULIN| PREDNISONE| REMICAID INFUSION| TRAMADOL| TRIAZOLAM| VENASOPRIL (BLOOD PRESSURE MED| VICTOZA| VITAMIN D3| VITAMIN E| ASPRIN| PREDNISONE| METHOTRIXATE| FLUOXETINE 1XDAY| REMICAID INFUSION| MAGNESIUM OXIDE| NOVOLOG U100 INSULIN| VITAMIN D3| VITAMIN E| VENASOPRIL (BLOOD PRESSURE MED| HTC (BLOOD PRESSURE MEDICINE)| B12 TABLET| FOLIC ACID| NIACIN| LASIX 2 TIMES A DAY| VICTOZA| ACETAMINOPHEN| MUCINEX| LORATADINE| DOCUSATE SODIUM TWICE A DAY| TRIAZOLAM| MULTIVITAMIN| NEUPRO PATCH| FISH OIL| IPRATROPIUM BROMIDE| TRAMADOL| ISOSORBIDE 2 TIMES A DAY