BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 4617045 · Received March 19, 2015

    Report

    Report Number
    1823260-2015-02187
    Event Type
    Malfunction
    Date Received
    March 19, 2015
    Date of Event
    February 17, 2015
    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
    IN, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. REFERENCE THE FOLLOWING MEDWATCHES WITH PATIENT IDENTIFIERS FOR THE FOLLOWING SYSTEMS: (B)(6) AVIVA SYSTEM 1; (B)(6) - AVIVA SYSTEM 2. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.

    Description of Event or Problem · 1

    CALLER REPORTED OBTAINING THE FOLLOWING BLOOD GLUCOSE VALUES FROM HIS AVIVA METER (SYSTEM 1) AND HIS WIFE'S AVIVA METER (SYSTEM 2). A.) 11:51 PM ON (B)(6) 2015: 90 MG/DL, AND 51 MG/DL (SYSTEM 1) COMPARED TO 40 MG/DL (12:01 AM (B)(6) 2015) AND 77 MG/DL (12:02 AM ON (B)(6) 2015) ON SYSTEM 2. B.) HI (GREATER THAN 600 MG/DL) ON SYSTEM 1 COMPARED TO 161 MG/DL ON SYSTEM 2 WITHIN 10 MINUTES. C.) 226 MG/DL (1047 AM), 253 MG/DL(10:48 AM), 73 MG/DL(10:51 AM), 460 MG/DL(11:01 AM) AND 100 MG/DL(1105 AM)- ALL ON SYSTEM 1. NO ADVERSE EVENT. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188951 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 493909

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male ASPIRIN| CALCIUM| CLONIDINE| GABAPENTIN| HUMALOG| MAGNESIUM OXIDE| RAPAMUNE| ASPIRIN| MAGNESIUM OXIDE| GABAPENTIN| CALCIUM| RAPAMUNE| HUMALOG| CLONIDINE