BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2961354 · Received February 14, 2013

    Report

    Report Number
    1823260-2013-00869
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 17, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN IF THE INITIAL REPORTER HAS OR INTENDS TO REPORT THE EVENT TO FDA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013: THE DRUG MANUFACTURER REPORTED, VIA MEDWATCH (B)(4), THAT A NURSE INDICATED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL IN (B)(6) 2013 FOR UNCONTROLLED BLOOD SUGARS. PRIOR TO ADMISSION, PATIENT WAS REPORTEDLY USING AN [UNSPECIFIED] ACCU-CHEK DEVICE TO MONITOR BLOOD GLUCOSE. NEITHER THE PATIENT NOR THE HEALTHCARE PROVIDER WERE AWARE OF THE POTENTIAL INTERACTION BETWEEN THE GLUCOSE MONITORING SYSTEM AND EXTRANEAL. PRIOR TO DISCHARGE FROM THE HOSPITAL, PATIENT WAS REPORTEDLY PROVIDED WITH A COMPATIBLE [UNSPECIFIED] GLUCOSE MONITORING SYSTEM. THE NURSE REPORTEDLY STATED THAT THE HYPOGLYCEMIC EVENT WAS RELATED TO EDUCATION AND COMMUNICATION ISSUES, AS OPPOSED TO THE POTENTIAL INTERACTION BETWEEN THE GLUCOSE MONITORING SYSTEM AND EXTRANEAL (AS SUGGESTED ON THE INITIAL MEDWATCH REPORT).

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT WAS ADMITTED TO THE HOSPITAL EXHIBITING SYMPTOMS OF HYPERGLYCEMIA. PATIENT WAS NOTED TO BE DIAPHORETIC AND, ALTHOUGH RESPONSIVE, REACTIONS WERE REPORTEDLY DELAYED. AT 12:30 PM, PATIENT'S BLOOD GLUCOSE WAS MEASURED ON THE INFORM SYSTEM WITH A RESULT OF 410 MG/DL. BASED ON THIS VALUE, PATIENT WAS GIVEN 12 UNITS NOVOLOG (ADMINISTRATION ROUTE NOT REPORTED). AT 12:51 PM, A SAMPLE WAS OBTAINED FROM THE PATIENT AND, WHEN TESTED IN THE FACILITY'S LABORATORY, MEASURED 250 MG/DL. PATIENT'S BLOOD GLUCOSE WAS RETESTED ON THE INFORM SYSTEM, AT 3:30 PM AND 4:00 PM, WITH RESULTS OF 102 MG/DL AND 93 MG/DL, RESPECTIVELY. REPORTER NOTED THAT, ALTHOUGH THERE WAS NO APPARENT CHANGE IN PATIENT'S SYMPTOMS DURING THE 30 MINUTES BETWEEN THE INFORM SYSTEM RESULTS, PATIENT WAS GIVEN ORANGE JUICE (AMOUNT NOT REPORTED) DUE TO DECLINING GLUCOSE VALUES. AT 4:20 PM, PATIENT WAS REPORTED TO BE UNRESPONSIVE AND AN ADDITIONAL LABORATORY GLUCOSE TEST WAS ORDERED WHICH RETURNED A RESULT OF 23 MG/DL. REPORTER STATED THAT PATIENT WAS IMMEDIATELY TREATED WITH D50 AND STARTED ON AN INTRAVENOUS D50 SOLUTION (250 ML, FOR 30 MINUTES, FOLLOWED BY 100 ML, PER 30 MINUTES THEREAFTER). ALTHOUGH REPORTER STATED THAT PATIENT BECAME RESPONSIVE, FOLLOWING D50 ADMINISTRATION, NEITHER THE TIME OF RECOVERY, NOR THE DURATION OF D50 TREATMENT WAS REPORTED. REPORTER NOTED THAT PATIENT IS ON PERITONEAL DIALYSIS, USING BOTH DIANEAL AND EXTRANEAL (THE LATTER, A LABELED INTERFERENT FOR COMFORT CURVE TEST STRIPS); HOWEVER, NO INFORMATION ABOUT WHEN PATIENT WAS LAST DIALYZED, PRIOR TO ADMISSION, WAS PROVIDED. REPORTER STATED THAT THE FACILITY WILL IMMEDIATELY CEASE MONITORING PATIENT'S GLUCOSE, WITH THE INFORM SYSTEM, NOTING THAT ALL SUBSEQUENT TESTS WILL BE PERFORMED IN THE FACILITY'S LAB. NO ADDITIONAL INFORMATION ABOUT TREATMENT RECEIVED, IF ANY, WAS PROVIDED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65637 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551837

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR Required Intervention EXTRANEAL| NOVOLOG| NEXIUM| LASIX| REGLAN| DIANEAL| LEXAPRO| PROMETHAZINE| HEPARIN| METOPROLOL| MEGESTROL| D50 SALINE SOLUTION| PANTOPRAZOLE| ZOFRAN| LANTUS