BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM II TEST STRIPS

    MDR report key: 3213134 · Received July 9, 2013

    Report

    Report Number
    1823260-2013-04138
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 13, 2013
    Report Date
    August 8, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K121679
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER STATES THAT THE FOLLOWING RESULTS WERE OBTAINED ON A NEONATE PATIENT, USING THE INFORM II SYSTEM COMPARED TO A LAB RESULT, WITHIN 10 MINUTES: 37 MG/DL (INFORM II) AND 57 MG/DL (LAB). THE LAB SAMPLE WAS SPUN AND TESTED WITHIN 30 MINUTES. THE NEONATE PATIENT WAS NOT TREATED BASED OFF OF THE METER RESULT. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. CALLER STATES THAT CONTROLS WERE RUN AND PASSED PRIOR TO THE INCIDENT; HOWEVER, ACTUAL RESULTS WERE NOT PROVIDED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313147 ACCU-CHEK ® INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 471207

    Patients

    Seq Age Sex Outcome Treatment
    1 001 DA ERYTHROMYCIN| UNSPECIFIED STANDARD NEONATAL INJECTIONS| NG FEEDING TUBE