BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® INFORM II TEST STRIPS

    MDR report key: 5485440 · Received March 8, 2016

    Report

    Report Number
    1823260-2016-00258
    Event Type
    Injury
    Date Received
    March 8, 2016
    Date of Event
    February 9, 2016
    Report Date
    May 16, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K121679
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETURN THE STRIPS. A SPECIFIC ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. THE CUSTOMER DID RETURN THE METER. THE RETURNED METER WAS TESTED WITH RETENTION STRIPS AND CONTROL SOLUTION. ALL OF THE RETURNED RESULTS ARE WITHIN ACCEPTABLE RANGE. THE ALLEGATION, IN THIS CASE, COULD NOT BE SUBSTANTIATED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER NO LONGER HAS THE STRIPS.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT WHILE USING THE ACCUCHEK INFORM II METER (SERIAL NUMBER (B)(4)) THE FOLLOWING RESULTS WERE OBTAINED: (B)(6) 2016 @ 12:35 PM, 110 MG/DL; (B)(6) 2016 @ 3:25 PM, 118 MG/DL; (B)(6) 2016 @ 3:30 PM, 21 MG/DL (ARTERIAL SAMPLE TESTED ON AN EPOC BLOOD GAS ANALYZER); (B)(6) 2016 @ 3:30 PM, 23 MG/DL (ARTERIAL SAMPLE TESTED ON LABORATORY ANALYZER); (B)(6) 2016 @ 3:43 PM, 122 MG/DL; (B)(6) 2016 @ 3:54 PM, 127 MG/DL. AT 3:25 PM, THE PATIENT HAD SYMPTOMS OF HYPOGLYCEMIA WITH THE BLOOD GLUCOSE OF 118 MG/DL. AT 3:30 PM, TWO ARTERIAL SAMPLES WERE DRAWN FOR ALTERNATIVE TESTING METHODS AND 25 ML OF GLUCOSE WAS ADMINISTERED. AT SOME POINT AFTER THE GLUCOSE WAS ADMINISTERED THE PATIENT NO LONGER HAD SYMPTOMS OF HYPOGLYCEMIA. THE EXACT TIME FRAME FOR THE RECOVERY IS NOT KNOWN. THE REPORTER COULD NOT VERIFY IF ALL OF THE RESULTS WERE FROM THE SAME VIAL OF STRIPS AND SHE SAID THIS INFORMATION WOULD NOT BE AVAILABLE. IT WAS REPORTED THAT THE PATIENT WAS STABLE AND AT THE TIME OF THE REPORT HE WAS STILL HOSPITALIZED IN THE PULMONARY CARE UNIT. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED, HOWEVER THE REPORTER STATES THE VIAL HAS BEEN USED AND THEREFORE THE STRIPS ARE NOT AVAILABLE TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141983 ACCU-CHEK ® INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 474128

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention