BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM II TEST STRIPS

    MDR report key: 19642460 · Received July 1, 2024

    Report

    Report Number
    1823260-2024-01888
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 5, 2024
    Report Date
    July 19, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    UDI-DI
    00365702428102
    PMA / PMN Number
    K121679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE ACCU-CHEK INFORM II METER IS (B)(6). THE CUSTOMER STATED THAT QCS ARE RUN EVERY 24 HOURS AND HAVE BEEN ACCEPTABLE. THE INVESTIGATION INSPECTED THE RETURNED VIAL. THERE WERE NO OBVIOUS SIGNS OF DAMAGE OR CONTAMINATION. THE INVESTIGATION TESTED THE RETURNED TEST STRIPS USING GLYCOLYZED BLOOD. INVESTIGATION RESULTS (IN MG/DL): 114, 125, 109, 112, 115, 108, 109, 105, 112, 109, 113, 113. ALL TESTING WITH THE RETURNED STRIPS PRODUCED ACCEPTABLE RESULTS AND NO STRIP DEFECTS WERE OBSERVED. THE INVESTIGATION TESTED THE VIAL'S INTEGRITY AND THE RESULT WAS ACCEPTABLE. THE INVESTIGATION CONFIRMED THE PRIMARY PACKAGING SEAL WAS ACCEPTABLE FOR THE RETURNED VIAL AND THERE WAS EVIDENCE TO SUPPORT THAT THE RETURNED PRODUCT WAS APPROPRIATELY SEALED. ON A REGULAR BASIS, ACCU-CHEK INFORM STRIPS OF LOTS CURRENTLY VALID IN THE MARKET ARE TESTED AS PART OF ROUTINE RETENTION TESTING AND RESULTS HAVE PASSED THE INTERNAL INSPECTION. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE GLUCOSE RESULT FOR ONE PATIENT TESTED WITH AN ACCU-CHEK INFORM II METER. THE METER RESULT AT 7:57 AM WAS 22 MG/DL. THIS RESULT DID NOT MATCH THE PATIENT¿S SYMPTOMS. THE METER RESULT AT 8:00 AM WAS 99 MG/DL. NO TREATMENT WAS PROVIDED BASED ON THIS RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785130 ACCU-CHEK INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 671094 00365702428102

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female ACETAMINOPHEN| ASPIRIN| ATORVASTATIN| DOCUSATE SODIUM| FENOFIBRATE| LEVOTHYROXINE| LOSARTAN| MELATONIN| MIRTAZAPINE| PANTOPRAZOLE| PIOGLITAZONE| PROPRANOL