BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TEST STRIPS

    MDR report key: 746945 · Received August 10, 2006

    Report

    Report Number
    1823260-2006-04028
    Event Type
    Injury
    Date Received
    August 10, 2006
    Date of Event
    December 7, 2004
    Report Date
    July 21, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED AT A HEALTHCARE FACILITY IN ANOTHER COUNTRY. THE NAME OF THE FACILITY AND CONTACT INFORMATION WERE NOT PROVIDED. ADDITIONALLY, THE SPECIFIC TYPE OF BLOOD GLUCOSE MONITORING SYSTEM WAS NOT PROVIDED.

    Description of Event or Problem · 1

    PATIENT REPORTEDLY EXPERIENCED CONFUSION, DISORIENTATION, SECONDARY HYPERHIDROSIS, DECREASED LEVEL OF CONSCIOUSNESS, AND SLOW RESPIRATIONS COINCIDENT TO EXTRANEAL THERAPY (A LABELED INTERFERENT FOR THE TEST STRIPS). PATIENT REPORTEDLY BECAME CONFUSED, DISORIENTED, SWEATY, AND WAS UNRESPONSIVE TO COMMANDS. PATIENT'S CONDITION SUBSEQUENTLY IMPROVED AND NO TREATMENT WAS RECEIVED. THE FOLLOWING DAY, PATIENT REPORTEDLY EXPERIENCED DECREASED LEVEL OF CONSCIOUSNESS AND SLOW RESPIRATIONS. PATIENT'S BLOOD GLUCOSE WAS REPORTEDLY TESTED, USING THE SUSPECT DEVICE, WITH RESULTS OF 14.5 MMOL/L (07:00), 14.9 MMOL/L (11:30), 19.2 MMOL/L (16:30), 12.9 MMOL/L (21:25), AND 14.3 MMOL/L (22:30). LABORATORY SERUM GLUCOSE VALUES, REPORTEDLY OBTAINED ON THE SAME DAY, WERE 3.5 MMOL/L (15:15), 1.8 MMOL/L (21:50), AND 3.0 MMOL/L (22:50). THE FOLLOWING DAY, PATIENT'S BLOOD GLUCOSE WAS REPORTEDLY TESTED, USING THE SUSPECT DEVICE, WITH A RESULT OF 15.6 MMOL/L AT 06:00. LABORATORY SERUM GLUCOSE VALUES WERE REPORTED TO BE 4.4 MMOL/L (05:40), 5.1 MMOL/L (12:08) AND 3.6 MMOL/L (1800). PATIENT WAS TREATED WITH DEXTROSE (50%) AND NARCAN, AFTER WHICH CONDITION REPORTEDLY IMPROVED. AT THIS TIME, PATIENT BLOOD GLUCOSE MONITORING, USING THE SUSPECT DEVICE, WAS DISCONTINUED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIAGNOSTICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R ACCU-CHEK BLOOD GLUCOSE MONITOR| EXTRANEAL (ICODEXTRIN 7.5%)