BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1387015 · Received May 15, 2009

    Report

    Report Number
    1823260-2009-03460
    Event Type
    Injury
    Date Received
    May 15, 2009
    Date of Event
    January 6, 2009
    Report Date
    May 15, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME EVENT REPORTED DRUG MANUFACTURER ON MEDWATCH.

    Description of Event or Problem · 1

    REPORTER STATED THAT A PATIENT, HOSPITALIZED FOR A KIDNEY TRANSPLANT, EXPERIENCED HYPOGLYCEMIA COINCIDENT WITH EXTRANEAL THERAPY (A LABELED INTERFERENT FOR COMFORT CURVE TEST STRIPS). REPORTER STATED THAT, FOLLOWING THE TRANSPLANT, PATIENT WAS ADMITTED TO THE FACILITY'S INTENSIVE CARE UNIT. PATIENT REPORTEDLY REQUESTED THAT THE STAFF USE HIS PERSONAL BLOOD GLUCOSE MONITORING SYSTEM, DUE TO TREATMENT WITH EXTRANEAL PRIOR TO ADMISSION AND ITS KNOWN INTERFERENCE WITH GDH-PQQ STRIP CHEMISTRY. REPORTER STATED THAT A NURSE DECLINED, INDICATING THAT THE INFORM SYSTEM WAS USED IN THE ICU. PATIENT'S BLOOD GLUCOSE WAS SUBSEQUENTLY TESTED, USING THE INFORM SYSTEM, WITH A RESULT GREATER THAN 250 MG/DL (EXACT VALUE WAS NOT PROVIDED). BASED ON THIS VALUE, A PHYSICIAN TREATED PATIENT WITH INSULIN (AMOUNT AND TYPE WAS NOT PROVIDED). FOLLOWING INSULIN ADMINISTRATION, PATIENT REPORTEDLY BECAME HYPOGLYCEMIC (WHICH WAS LATER CONFIRMED BY A LAB TEST). NO INFORMATION ABOUT TREATMENT RECEIVED FOR HYPOGLYCEMIA WAS PROVIDED. REPORTER NOTED THAT, LATER THAT EVENING, PATIENT EXPERIENCED MYOCARDIAL INFARCTION, PROLONGING HIS HOSPITALIZATION. FOLLOWING THE HYPOGLYCEMIC EVENT, PATIENT'S BLOOD GLUCOSE WAS MONITORED USING HIS ASCENICA DEX2 MONITOR. NO ADDITIONAL INFORMATION ABOUT TREATMENT RECEIVED WAS PROVIDED. REPORTER NOTED THAT MYOCARDIAL INFARCTION WAS RESOLVED UPON DISCHARGE AND THE KIDNEY TRANSPLANT WAS A SUCCESS. THE INFORM SYSTEM WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention DIANEAL AMBU-FLEX| EXTRANEAL VIAFLEX| INSULIN (TYPE UNK)