BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2221749 · Received August 24, 2011

    Report

    Report Number
    1823260-2011-04539
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 9, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDWATCH FORM, FROM THE USER FACILITY, WAS ALSO SUBMITTED FOR THIS EVENT (UF/IMPORTER REPORT NUMBER (B)(4)).

    Description of Event or Problem · 1

    REPORTER STATED THAT A POST RENAL TRANSPLANT PATIENT WAS ADMITTED TO THE HOSPITAL, ON (B)(6) 2011, WITH FEVER AND ELEVATED BLOOD GLUCOSE (VALUES GREATER THAN 600 MG/DL). DURING HOSPITALIZATION, PATIENT REPORTEDLY EXPERIENCED "SEIZURE-LIKE ACTIVITY" AND MULTIPLE HYPOGLYCEMIC EPISODES. REPORTER NOTED THAT PATIENT HAS END-STAGE RENAL DISEASE, TREATED WITH PERITONEAL DIALYSIS (PD). WHILE HOSPITALIZED, PERITONEAL DIALYSIS WAS PERFORMED USING DIANEAL; HOWEVER, REPORTER STATED THAT PATIENT HAD BEEN USING THE DIALYSATE EXTRANEAL (A LABELED INTERFERENT FOR COMFORT CURVE TEST STRIPS) AT HOME. ALTHOUGH PATIENT REPORTEDLY WORE A MEDIALERT BRACELET AND HAD DOCUMENTATION, AT HOME, WARNING OF THE POTENTIAL DRUG/DEVICE INTERACTION BETWEEN EXTRANEAL AND GDH-PQQ TYPE GLUCOSE MONITORING TEST STRIPS, THE PATIENT DID NOT SHARE THIS INFORMATION WITH HOSPITAL STAFF BEFORE THE SEIZURES HAD OCCURRED. ON AN UNSPECIFIED DATE, PATIENT'S HOME PD NURSE WAS CONTACTED, AT WHICH TIME THE HOSPITAL LEARNED THAT ICODEXTRIN (EXTRANEAL) WAS BEING USED FOR HOME DIALYSIS. ALTHOUGH THE REPORTER NOTED THAT PATIENT EXPERIENCED RECURRENT HYPOGLYCEMIA, REQUIRING CORRECTIVE D50 ADMINISTRATION, NO SPECIFIC INFORMATION WAS PROVIDED ABOUT WHEN THE "SEIZURE-LIKE ACTIVITY" OCCURRED AND WHAT TREATMENT, IF ANY, WAS ADMINISTERED TO CORRECT. TWO WEEKS AFTER THE PRELIMINARY DETAILS OF THE EVENT WERE REPORTED TO THE MANUFACTURER, THE USER-FACILITY FAXED A LIST OF MEDICATIONS ADMINISTERED TO PATIENT, WHILE HOSPITALIZED, ALONG WITH BLOOD GLUCOSE RESULTS OBTAINED BOTH ON THE INFORM SYSTEM AND IN THE FACILITY'S LABORATORY (SUMMARY BELOW). TIMES ASSOCIATED WITH THE LABORATORY VALUES, LISTED BELOW ARE THE TIMES THAT THE RESULTS WERE REPORTED OUT; THE TIME THAT THE SAMPLES WERE OBTAINED WAS NOT KNOWN BY THE REPORTER. (B)(6) 2011 - 06:41 - BLOOD GLUCOSE = HI [GREATER THAN 600 MG/DL] (INFORM SYSTEM) - 06:44 - BLOOD GLUCOSE = HI (INFORM SYSTEM) - 07:10 - BLOOD GLUCOSE = 442 MG/DL (LAB) - 07:26 - 6 UNITS REGULAR INSULIN, INJECTION - 11:20 - BLOOD GLUCOSE = 348 MG/DL (INFORM SYSTEM) - 11:50 - 3.5 UNITS/IV INSULIN ASPART - 13:00 - 3.5 UNITS/IV INSULIN ASPART - 13:03 - BLOOD GLUCOSE = 272 MG/DL - 14:15 - 3.5 UNITS/IV INSULIN ASPART - 14:25 - BLOOD GLUCOSE = 221 MG/DL (INFORM SYSTEM) - 15:30 - 3.5 UNITS/IV INSULIN ASPART - 15:30 - BLOOD GLUCOSE = 178 MG/DL (INFORM SYSTEM) - 16:30 - 3.5 UNITS/IV INSULIN ASPART - 16:33 - BLOOD GLUCOSE = 183 MG/DL (INFORM SYSTEM) - 17:00 - PATIENT REFUSED INSULIN INJECTION - 17:26 - BLOOD GLUCOSE = 48 MG/DL (LAB) - PATIENT TREATED WITH D50 (AMOUNT AND EXACT TIME NOT REPORTED) - 17:30 - 4.5 UNITS/IV INSULIN ASPART - 17:34 - BLOOD GLUCOSE = 166 MG/DL (INFORM SYSTEM) - 18:30 - 4.5 UNITS/IV INSULIN ASPART - 18:35 - BLOOD GLUCOSE = 188 MG/DL (INFORM SYSTEM) - 19:30 - 5.5 UNITS/IV INSULIN ASPART - 19:37 - BLOOD GLUCOSE = 177 MG/DL (INFORM SYSTEM) - 20:30 - 5.5 UNITS/IV INSULIN ASPART - 20:31 - BLOOD GLUCOSE = 176 MG/DL (INFORM SYSTEM) - 21:21 - BLOOD GLUCOSE = 163 MG/DL (INFORM SYSTEM) - 22:21 - BLOOD GLUCOSE = 210 MG/DL (INFORM SYSTEM) - 22:30 - 5.5 UNITS/IV INSULIN ASPART - 23:27 - BLOOD GLUCOSE = 175 MG/DL (INFORM SYSTEM) - 23:48 - BLOOD GLUCOSE = 168 MG/DL (INFORM SYSTEM) - 23:50 - BLOOD GLUCOSE 45 MG/DL (LAB) - PATIENT TREATED WITH D50 (AMOUNT AND EXACT TIME NOT REPORTED) (B)(6) 2011 - 00:39 - BLOOD GLUCOSE = 176 MG/DL (INFORM SYSTEM) - 00:45 - 5.5 UNITS/IV INSULIN ASPART - 02:45 - 5.5 UNITS/IV INSULIN ASPART - 02:49 - BLOOD GLUCOSE = 158 MG/DL (INFORM SYSTEM) - 04:45 - 5.5 UNITS/IV INSULIN ASPART - 04:53 - BLOOD GLUCOSE = 148 MG/DL (INFORM SYSTEM) - 06:45 - BLOOD GLUCOSE = 136 MG/DL (INFORM SYSTEM) - 06:45 - 5.5 UNITS/IV INSULIN ASPART - 07:01 - BLOOD GLUCOSE = 140 MG/DL (INFORM SYSTEM) - 08:35 - BLOOD GLUCOSE = 210 MG/DL (INFORM SYSTEM) - 10:29 - BLOOD GLUCOSE = 310 MG/DL (INFORM SYSTEM) - 13:15 - BLOOD GLUCOSE = 513 MG/DL (INFORM SYSTEM) - 13:23 - 10 UNITS ASPART/INJECTION - 13:46 - BLOOD GLUCOSE = 536 MG/DL (INFORM SYSTEM) - 14:16 - BLOOD GLUCOSE = 530 MG/DL (INFORM SYSTEM) - 14:20 - 25 UNITS GLARGINE/INJECTION - 15:29 - BLOOD GLUCOSE = HI (INFORM SYSTEM) - 16:57 - BLOOD GLUCOSE = 427 MG/DL (INFORM SYSTEM) - 17:00 - 6 UNITS/IV INSULIN ASPART - 17:00 - 5 UNITS ASPART/INJECTION - 18:23 - BLOOD GLUCOSE = 319 MG/DL (INFORM SYSTEM) - 18:30 - 6 UNITS/IV INSULIN ASPART - 19:30 - 6 UNITS/IV INSULIN ASPART - 19:35 - BLOOD GLUCOSE = 223 MG/DL (INFORM SYSTEM) - 20:30 - 6 UNITS/IV INSULIN ASPART - 20:40 - BLOOD GLUCOSE = 169 MG/DL (INFORM SYSTEM) - 21:27 - BLOOD GLUCOSE = 159 MG/DL (INFORM SYSTEM) - 21:30 - 6 UNITS/IV INSULIN ASPART - 21:54 - BLOOD GLUCOSE = 25 MG/DL (LAB) - PATIENT TREATED WITH D50 (AMOUNT AND EXACT TIME NOT REPORTED) - 22:20 - 6 UNITS/IV INSULIN ASPART - 22:22 - BLOOD GLUCOSE = 118 MG/DL (INFORM SYSTEM) - 22:45 - 15 UNITS GLARGINE/INJECTION - PATIENT TREATED WITH 25 GRAMS D50 (EXACT TIME NOT REPORTED) (B)(6) 2011 - 00:05 - BLOOD GLUCOSE = 172 MG/DL (INFORM SYSTEM) - 00:56 - BLOOD GLUCOSE = 162 MG/DL (INFORM SYSTEM) - 02:18 - BLOOD GLUCOSE = 171 MG/DL (INFORM SYSTEM) - 03:58 - BLOOD GLUCOSE = 174 MG/DL (INFORM SYSTEM) - 05:02 - BLOOD GLUCOSE = 201 MG/DL (INFORM SYSTEM) - 06:47 - BLOOD GLUCOSE = 191 MG/DL (INFORM SYSTEM) - 07:00 - PATIENT REFUSED INSULIN - 09:00 - 15 UNITS GLARGINE/INJECTION - 09:47 - BLOOD GLUCOSE = 198 MG/DL (INFORM SYSTEM) - 11:00 - PATIENT REFUSED INSULIN - 11:57 - BLOOD GLUCOSE = 184 MG/DL (INFORM SYSTEM) - 13:26 - BLOOD GLUCOSE = 138 MG/DL (INFORM SYSTEM) - 14:15 - BLOOD GLUCOSE = 129 MG/DL (LAB) (B)(6) 2011 - 00:15 - BLOOD GLUCOSE = 142 MG/DL (LAB) - 12:55 - BLOOD GLUCOSE = 204 MG/DL (INFORM SYSTEM) - 05:00 - 3 UNITS/IV INSULIN ASPART - 07:30 - 5 UNITS ASPART/INJECTION - 09:00 - 15 UNITS GLARGINE/INJECTION - 09:30 - 3 UNITS/IV INSULIN ASPART - 11:00 - 5 UNITS ASPART/INJECTION - 13:00 - 3 UNITS/IV INSULIN ASPART - 16:30 - 3 UNITS/IV INSULIN ASPART - 17:00 - 3 UNITS ASPART/INJECTION - 23:40 - BLOOD GLUCOSE = 208 MG/DL (LAB) AT THE TIME OF THE REPORT, THE PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL. REPORTER NOTED THAT SHE BELIEVED THE PATIENT HAD RECOVERED FROM THE HYPOGLYCEMIC EPISODES WITHOUT FURTHER SEQUELAE. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT 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 ROCHE DIAGNOSTICS NA 551490

    Patients

    Seq Age Sex Outcome Treatment
    1 037 YR Required Intervention HYDRALAZINE| DIANEAL LOW CALCIUM/1.5% DEXTROSE| DEXTROSE 50% IN WATER (DW50)| PIPERACILLIN TAZOBACTAM| AMITRIPTYLINE| CALCIUM ACETATE| EXTRANEAL| PERCOCET| POTASSIUM CHLORIDE| HEPARIN| LEVOFLOXACIN| INSULIN ASPART| TWO UNITS PACKED RED CELLS| ALTEPLASE| PERITONEAL DIALYSIS EQUIPMENT| PANTOPRAZOLE| LORAZEPAM| OXYCODONE| VANCOMYCIN| RENAGEL| PREDNISONE| INSULIN GLARGINE| INSULIN REGULAR| MAGNESIUM HYDROXIDE| MAGNESIUM SULFATE| NORMAL SALINE