BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLOTRON HEMOGLOBIN 30

    MDR report key: 2018224 · Received March 14, 2011

    Report

    Report Number
    1823260-2011-01378
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 10, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KHG
    PMA / PMN Number
    K934064
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE VIAL OF TEST STRIPS WAS RETURNED BY THE CUSTOMER FOR INVESTIGATION. THE CUSTOMER'S MATERIALS AND RETENTION SAMPLES WERE TESTED AND WERE FOUND TO BE WITHIN SPECIFICATION. ALL MEASUREMENTS GAVE RESULTS WITHIN SPECIFIED RANGES. INTERNAL CAPILLARY BLOOD TESTING REVEALED THE QUALITY OF THE BATCHES USED DURING TESTING WERE WITHIN SPECIFICATION. NO MALFUNCTION WAS DETECTED. SINCE THE INVESTIGATION SHOWED THE MATERIAL MET SPECIFICATION, IT WAS RECOMMENDED THE CUSTOMER CHECK SAMPLE COLLECTION AND PREPARATION AS OUTLINED IN THE PACKAGE INSERT. NO ADVERSE EVENTS WERE REPORTED ASSOCIATED WITH THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER CONDUCTED PULIC HEALTH CARE PROFILES AT DIFFERENT LOCATIONS SEVERAL DIFFERENT DAYS DURING A PERIOD OF SEVERAL WEEKS. THE HEALTH PROFILES INCLUDED GLUCOSE, CHOLESTEROL AND HEMOGLOBIN TESTING. THE PARTICIPANTS WERE FEMALES (B)(6) AND MALES (B)(6). THE TOTAL NUMBER OF PARTICIPANTS WAS NOT PROVIDED. THE CUSTOMER PROVIDED 39 PATIENT RESULTS TESTED IN THREE DIFFERENT CITIES USING THE SAME HEMOGLOBIN STRIP LOT NUMBER 20332603. HEMOGLOBIN RESULTS FROM THREE OF THE PARTICIPANTS WERE DISCREPANT. PARTICIPANT 1, MALE, INITIAL RESULT WAS <50 G/L. THE PARTICIPANT WAS TESTED TWO MORE TIMES. THE FIRST REPEAT RESULT WAS >200 G/L. THE SECOND REPEAT RESULT WAS 165 G/L. PARTICIPANT 2, INITIAL RESULT WAS >200 G/L. THE REPEAT RESULTS WERE >200 AND 157 G/L. THE DATE OF TESTING WAS NOT PROVIDED. PARTICIPANT 3, INITIAL RESULT WAS WAS >200 G/L. THE REPEAT RESULTS WERE >200 G/L AND 176 G/L. THE DATE OF TESTING WAS NOT PROVIDED. THE PARTICIPANTS WERE RECOMMENDED TO VISIT THERE ORDINARY HEALTH CARE PROVIDER FOR FURTHER INVESTIGATION. NO ADVERSE EVENTS HAVE BEEN ALLEGED REGARDING THE DISCREPANCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLOTRON HEMOGLOBIN 30 WHOLE BLOOD HEMOGLOBIN DETERMINATION KHG ROCHE DIAGNOSTICS NA 20332603

    Patients

    Seq Age Sex Outcome Treatment
    1