BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM II INSTRUMENT WITH RF CARD

    MDR report key: 12674066 · Received October 21, 2021

    Report

    Report Number
    1823260-2021-03075
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 29, 2021
    Report Date
    May 18, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    UDI-DI
    04015630925469
    PMA / PMN Number
    K012210
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE METER WAS RECEIVED FOR INVESTIGATION. THE CUSTOMER'S METER BARCODE FUNCTIONALITY WAS TESTED USING SAMPLE BARCODES. VARIOUS SYMBOLOGIES WERE SCANNED USING THE CUSTOMER METER MULTIPLE TIMES EACH. ALL OF THE BARCODES WERE SCANNED CORRECTLY. NO ISSUE WAS FOUND WITH THE BARCODE SCANNING FUNCTION OF THE METER. BARCODE NUMBERS WERE TRANSFERRED TO DMS AS PATIENT ID AND NO ISSUES WERE FOUND. THE DEVICE WAS DISASSEMBLED FOR FURTHER INVESTIGATION. THE VISUAL INSPECTION OF THE ELECTRONIC PARTS SHOWED NO ABNORMALITIES. THERE WAS NO CONTAMINATION FOUND. THE BARCODE SCANNER WINDOW HAD LIGHT SCUFFS BUT THIS DID NOT AFFECT THE SCANNING PERFORMANCE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE INVESTIGATION DETERMINED THAT THE ISSUE WAS DUE TO THE QUALITY OF THE BARCODE THE CUSTOMER USED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN ANY MATERIALS FOR INVESTIGATION. WITHOUT THESE MATERIALS TO INVESTIGATE, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE METER WAS REQUESTED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE INITIAL REPORTER HAD AN ISSUE WHILE SCANNING PATIENT ID BARCODES ON AN ACCU-CHEK INFORM II METER. THE REPORTER STATED WHEN SHE SCANS THE PATIENT ID, IT SCANS AS ONE NUMBER BUT ACTUALLY CROSSED INTO THE SOFTWARE AS ANOTHER NUMBER. THE PATIENT ID SAMPLE IS (B)(4). HOWEVER, IT SHOWS UP IN THE SOFTWARE AS 100589. THERE WAS NO HARM TO ANY PATIENT REPORTED DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569367 ACCU-CHEK INFORM II INSTRUMENT WITH RF CARD BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA 04015630925469

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown