BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCU-CHEK ® INFORM II TEST STRIPS

    MDR report key: 5503953 · Received March 16, 2016

    Report

    Report Number
    1823260-2016-00296
    Event Type
    Death
    Date Received
    March 16, 2016
    Date of Event
    February 19, 2016
    Report Date
    March 16, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K121679
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE USING THE ACCUCHEK INFORM II METER (SERIAL NUMBER (B)(4)) THEY HAD AN ISSUE WITH DISCREPANT RESULTS BETWEEN THE METER AND LABORATORY READINGS. THE PATIENT HAS DIED. THE PATIENT WAS STATED TO HAVE END STAGE RENAL DISEASE AND WAS ON PERITONEAL DIALYSIS. THE FOLLOWING SEQUENCE OF EVENTS OCCURRED PRIOR TO THE DEATH OF THE PATIENT: ON (B)(6) 2016 7:20 PM ¿ THE PATIENT RECEIVED INSULIN. THE DOSE WAS 14 UNITS OF LEVEMIR AND 3 UNITS OF NOVOLOG. ON (B)(6) 2016 ¿ 9:11 PM - THE PATIENT HAD A BLOOD GLUCOSE VALUE OF 126 MG/DL WHEN TESTED WITH THE METER. ON (B)(6) 2016 ¿ 7:00 AM ¿ THE DOCTOR CONSULTED WITH THE PATIENT. THE DOCTOR¿S NOTES INDICATE THAT THE PATIENT DENIED ANY NAUSEA, DIARRHEA, OR VOMITING. ON (B)(6) 2016 ¿ 7:29 AM ¿ BLOOD WORK DRAWN. THE PERSON WHO DREW THE BLOOD STATED THE PATIENT WAS "NOT RESPONSIVE AT THE TIME OF THE BLOOD DRAW" AND "SHE WASN¿T SURE IF HE WAS JUST SLEEPING". ON (B)(6) 2016 ¿ 7:40 AM ¿ THE NURSE ON THE FLOOR TESTED THE PATIENT WITH THE METER AND OBTAINED A BLOOD GLUCOSE RESULT OF 114 MG/DL. ON (B)(6) 2016 ¿ 8:13 AM ¿ A LABORATORY BLOOD GLUCOSE RESULT CAME BACK AS 28 MG/DL. DUE TO THE CRITICAL NATURE, THE RESULT WAS REPEATED IN THE LAB. THE METHOD OF TESTING USED IN THE LABORATORY WAS NOT PROVIDED. ON (B)(6) 2016 ¿ 8:19 AM- THE SECOND RESULT CAME BACK AS 29 MG/DL. WHEN THE LOW RESULT WAS RELAYED TO THE FLOOR THE CALLER WAS INFORMED THAT THE PATIENT HAD CODED AND THEY WERE WORKING TO REVIVE HIM. TREATMENT WAS PROVIDED TO THE PATIENT AT THE TIME HE CODED. THE CUSTOMER PROVIDED THE FOLLOWING TREATMENT INFORMATION AS DOCUMENTED IN THE PATIENT¿S CHART: "30 MINUTES OF CPR, 4 DOSES OF EPINEPHRINE, PATIENT INTUBATED, SHOCKED 5 TIMES, PATIENT GIVEN 300 MG OF AMIODARONE, PATIENT GIVEN A DOSE OF CALCIUM GLUCONATE." ON (B)(6) 2016 ¿ 8:29 AM - THE PATIENT WAS PRONOUNCED DEAD. THE CUSTOMER PROVIDED THE FOLLOWING INFORMATION FROM THE PATIENT¿S CHART: "MOST LIKELY IMMEDIATE CAUSE OF DEATH A POSSIBLE MYOCARDIAL INFARCTION RESULTING IN CARDIAC ARREST IN THE SETTING OF HYPOGLYCEMIA, HYPOTENSION RELATED TO C. DIFFICILE COLITIS. IN ADDITION DUE TO THE DISCREPANCY IN THE LAB RESULT AND FINGER ACCU-CHEK PATIENT COULD NOT BE GIVEN DEXTROSE 50%." THE CUSTOMER STATED CONTROLS ARE TESTED ON THE METER REGULARLY. CONTROLS WERE TESTED ON THE METER ON (B)(6) 2016 AND 3:35 AM AND ON (B)(6) 2016 AT 10:06 AM. ALL RESULTS WERE WITHIN SPECIFICATION. THE CUSTOMER RETURNED THE ACCUCHEK INFORM II METER (SERIAL NUMBER (B)(4)) AND FOUR VIALS OF STRIPS (LOT 473375 EXPIRATION 06/30/2016) FOR INVESTIGATION. IT IS NOT KNOWN WHICH VIAL OF STRIPS WAS USED WHEN TESTING THE PATIENT. THE STRIPS WERE TESTED AND ALL RESULTS ARE WITHIN ACCEPTABLE RANGE. ROUTINE RETENTION TESTING IS PERFORMED. NO PRODUCT ISSUES HAVE BEEN IDENTIFIED. THE PATIENT HAD A HISTORY OF PERIPHERAL VASCULAR DISEASE. THE LIMITATIONS SECTION OF THE PACKAGE INSERT STATES: "IF PERIPHERAL CIRCULATION IS IMPAIRED, COLLECTION OF CAPILLARY BLOOD FROM THE APPROVED SAMPLE SITES IS NOT ADVISED AS THE RESULTS MIGHT NOT BE A TRUE REFLECTION OF THE PHYSIOLOGICAL BLOOD GLUCOSE LEVEL. THIS MAY APPLY IN THE FOLLOWING CIRCUMSTANCES: SEVERE DEHYDRATION AS A RESULT OF DIABETIC KETOACIDOSIS OR DUE TO HYPERGLYCEMIC HYPEROSMOLAR NON-KETOTIC SYNDROME, HYPOTENSION, SHOCK, DECOMPENSATED HEART FAILURE NYHA CLASS IV, OR PERIPHERAL ARTERIAL OCCLUSIVE DISEASE." THE PRODUCT MEETS SPECIFICATION AND NO PRODUCT PROBLEM WAS FOUND. REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159695 ACCU-CHEK ® INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 473375

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death "VENIAFAXINE"