BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM II TEST STRIPS

    MDR report key: 9883084 · Received March 26, 2020

    Report

    Report Number
    1823260-2020-00845
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    March 2, 2020
    Report Date
    March 26, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K121679
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT STRIP LOT 477954 WAS USED ON THE FLOOR BY THE STAFF AND STRIP LOT 477716 WAS USED BY THE CUSTOMER N HER OFFICE TO PERFORM CONTROL TESTS. IT WAS VERIFIED THAT BOTH LEVEL OF CONTROLS WERE RAN ON METER (B)(4) AND (B)(4) PRIOR TO THE QUESTIONABLE RESULTS AND PASSED. A HIGH LEVEL CONTROL WAS RAN AFTER THE QUESTIONABLE RESULTS WHICH FAILED TWICE ON METER (B)(4). USING METER (B)(4) THE CUSTOMER RAN BOTH LOW LEVEL AND HIGH LEVEL CONTROLS AND BOTH FAILED. LOW LEVEL CONTROL RANGE IS 30MG/DL - 60MG/DL. HIGH LEVEL CONTROL RANGE IS 261MG/DL - 353MG/DL. THE CUSTOMER STATED THEY GOT A RESULT OF LO AND 19MG/DL WITH LOW LEVEL CONTROL AND 268MG/DL WITH HIGH LEVEL CONTROL. THE CUSTOMER'S METERS, TEST STRIPS (LOT 477716, 4 STRIPS)AND CONTROLS WERE PROVIDED FOR INVESTIGATION. STRIP LOT 477954 WAS NOT RETURNED FOR INVESTIGATION. TESTING RESULTS: (B)(4). LEVEL 1 QC 1: 48 MG/DL. LEVEL 1 QC 2: 46 MG/DL.. LEVEL 1 QC 3: 45 MG/DL LEVEL 2 QC 1: 315 MG/DL LEVEL 2 QC 2: 310 MG/DL LEVEL 2 QC 3: 309 MG/DL (B)(4). LEVEL 1 QC 1: 46 MG/DL. LEVEL 1 QC 2: 45 MG/DL. LEVEL 1 QC 3: 46 MG/DL. LEVEL 2 QC 1: 310 MG/DL. LEVEL 2 QC 2: 317 MG/DL. LEVEL 2 QC 3: 312 MG/DL. THE OBTAINED QC VALUES WERE IN THE ALLOWED RANGE OF THE USED COMBINATION STRIP LOT - QC LOT. ALL MEASUREMENTS WERE WITHOUT ERROR MESSAGES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF A DISCREPANT GLUCOSE RESULT, FOR A NEONATE, WITH ACCU-CHEK INFORM II METER SERIAL NUMBER WHEN COMPARED TO ACCU-CHEK INFORM II METER SERIAL NUMBER (B)(4). AT 10:21AM A HEELSTICK WAS PERFORMED ON INFORM II (B)(4). THE RESULT WAS 15MG/DL. AT 10:24AM A HEELSTICK WAS PERFORMED ON INFORM II (B)(4). THE RESULT WAS 82MG/DL. THE CUSTOMER DID NOT BELIEVE THE RESULTS OBTAINED ON METER (B)(4). THE PATIENT IS CURRENTLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348024 ACCU-CHEK ® INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 477954

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA