BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOSP SS FLEXX METER

    MDR report key: 2036997 · Received April 1, 2011

    Report

    Report Number
    2939301-2011-02743
    Event Type
    Death
    Date Received
    April 1, 2011
    Date of Event
    January 3, 2011
    Report Date
    March 8, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER INDICATED THAT ON THE SAME DAY, (B)(6) 2011, AT 9:14 AM, A CT OF THE HEAD REVEALED "DIFFUSE BRAIN SWELLING." ACCORDING TO THE REPORTER, ON (B)(6) 2011, AT 1 AM, 3:40 AM, AND 7:09 AM, BLOOD GLUCOSE READINGS OF "127 MG/DL, 117 MG/DL, AND 102 MG/DL," RESPECTIVELY, WERE OBTAINED ON THE LAB INSTRUMENT, WHILE AT 12:35 AM AND 5:57 AM READINGS OF "136 MG/DL AND 121 MG/DL," RESPECTIVELY, WERE OBTAINED ON THE SURESTEP FLEXX METER. THE PATIENT'S HEMATOCRIT ON (B)(6) 2011, THE DATE OF THESE READINGS, WAS 32.8%, WITHIN THE LABELED RANGE (25% TO 60%) OF THE DEVICE. ACCORDING TO THE REPORTER, BETWEEN THE NIGHT OF (B)(6) 2011, AND (B)(6) 2011, THE PATIENT WAS DECLARED BRAIN DEAD PER A CLINICAL EXAM. A SECOND CLINICAL EXAM CONFIRMED THE PATIENT'S CONDITION ON (B)(6) 2011, AT 12:15 PM AND THE PATIENT WAS DECLARED DEAD. A DEATH CERTIFICATE HAS NOT BEEN PRODUCED AS OF (B)(6) 2011. THIS COMPLAINT IS BEING REPORTED BECAUSE THE HOSPITAL FACILITY REPORTED THAT THE PATIENT EXPERIENCED SEVERE HYPOGLYCEMIA DUE TO TREATMENT BASED ON GLUCOSE READINGS ON THE LIFESCAN METER. THE 510K #K081019. LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE SUBJECT TEST STRIP LOT# FROM RETAINS PASSED. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2011, LIFESCAN RECEIVED NOTIFICATION FROM FDA THAT A DEATH OCCURRED IN A HOSPITAL FACILITY WHERE THE ONETOUCH SURESTEP FLEXX SYSTEM WAS USED. SUBSEQUENTLY, THIS MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE RISK MANAGER/REPORTER TO OBTAIN MORE INFORMATION SURROUNDING THE EVENT. THE INFORMATION IN THIS REPORT IS DERIVED SOLELY FROM INFORMATION PROVIDED BY THE REPORTING HOSPITAL, AND BASED ON LIFESCAN'S REVIEW OF THE LIMITED MEDICAL RECORDS PROVIDED. LIFESCAN HAS REQUESTED THAT THE METER AND TEST STRIPS IN QUESTION BE RETURNED TO IT FOR INSPECTION, BUT THE REPORTING HOSPITAL HAS DECLINED TO PROVIDE THE SUBJECT METERS. ACCORDING TO THE MEDICAL RECORDS/REPORTER, THE PATIENT WHO HAD PASSED AWAY HAD A MEDICAL HISTORY OF KIDNEY TRANSPLANT ((B)(6) 2010) AND HYPERTENSION. SHE WAS HOSPITALIZED ON (B)(6) 2010, FOR UROSEPSIS. SHE WAS EVENTUALLY ADMITTED TO THE INTENSIVE CARE UNIT (ICU) ON (B)(6) 2010. DURING HER HOSPITAL STAY SHE WAS NOTED TO BE IMMUNOCOMPROMISED AND HAVE ELECTROLYTE ABNORMALITIES. SHE HAD DEVELOPED SIGNIFICANT RESPIRATORY ISSUES AND WAS PLACED ON A VENTILATOR ON (B)(6) 2010. SHE WAS EXTUBATED ON (B)(6) 2010, BUT REQUIRED RE-INTUBATION LATER THE SAME DAY. REPORTEDLY, HER LEVEL OF SEDATION VARIED DURING THIS TIME PERIOD AND HER RESPIRATORY CONDITION DID NOT IMPROVE. THE REPORTER CLAIMED THAT AT 2:45 AM AND 3:22 AM ON (B)(6) 2011, INACCURATELY HIGH READINGS OF "435 AND 370 MG/DL" RESPECTIVELY WERE OBTAINED USING THE SURESTEP FLEXX SYSTEM. ACCORDING THE REPORTER, THE PATIENT ALLEGEDLY DID NOT EXHIBIT ANY SYMPTOMS AS SHE WAS SEDATED ON A VENTILATOR. ACCORDING TO THE REPORTER, AT 4:10 AM, A READING OF "383 MG/DL" WAS OBTAINED ON THE SUBJECT METER, AND THE PATIENT WAS GIVEN AN INSULIN INFUSION TITRATION BASED ON THE SURESTEP METER READINGS. ACCORDING TO THE MEDICAL RECORDS, A LAB RESULT OF "2 MG/DL" WAS OBTAINED ON THE PATIENT'S VENOUS SAMPLE COLLECTED AROUND 4:00 AM. IT WAS NOTED THAT HER "NEUROLOGICAL CHECK" REMAIN UNCHANGED FROM THE PRIOR ASSESSMENT. AT 5:30 AM, A SUBSEQUENT LAB RESULT OF "2 MG/DL" CONFIRMED THE PATIENT'S INITIAL LAB RESULT. THE SECOND LAB RESULT OF "2 MG/DL" WAS NOTED TO BE FROM THE SAME VENOUS SAMPLE COLLECTED AT 4 AM. REPORTEDLY, TREATMENT CONTINUED BASED ON THE ALLEGEDLY ELEVATED READINGS OF THE SURESTEP FLEXX METER DESPITE THE LOW READINGS OBTAINED IN THE LAB. ACCORDING TO THE REPORTER A LAB SPECIMEN COLLECTED AT 6 AM GAVE A RESULT OF "3 MG/DL," WHILE THE SURESTEP FLEXX METER RESULT ON A SAMPLE TAKEN AT 6:01 AM READ "480 MG/DL." THE REPORTER CLAIMED THAT THERE WAS NO TREATMENT BASED ON THIS LAB RESULT. ANOTHER BLOOD GLUCOSE READING OF LESS THAN "1 MG/DL" WAS OBTAINED FROM THE LAB AT 9:47 AM WHILE AT 10:16 AM A RESULT OF "291 MG/DL" WAS OBTAINED ON THE SURESTEP METER. ACCORDING TO THE REPORTER, AT AROUND THE SAME TIME, MULTIPLE PROVIDERS BEGAN TO QUESTION THE ACCURACY OF THE METER. ONE OF THE NURSES (NOT KNOWN TO BE DIABETIC) TESTED HER OWN BLOOD GLUCOSE AT "363 MG/DL." ACCORDING TO THE MEDICAL RECORDS/REPORTER THE NURSE TESTED HERSELF WITH A NEW VIAL OF TEST STRIPS AND RECEIVED A BLOOD GLUCOSE READING OF "89 MG/DL." INSULIN INFUSION TREATMENT BASED ON THE SURESTEP METER READINGS WAS DISCONTINUED AROUND 10 AM. ACCORDING TO THE REPORTER, AT AROUND 11:04 AM, THE PATIENT RECEIVED TWO "AMPS" OF DEXTROSE, AND AN INFUSION OF D5W AT 100 CC PER HOUR WAS STARTED. THE PATIENT'S BLOOD GLUCOSE FROM A SPECIMEN COLLECTED AT 11:20 CAME BACK FROM THE LAB AS "303 MG/DL." A THIRD "AMP" OF DEXTROSE WAS ADMINISTERED AT 11:29 AM. THE PATIENT'S BLOOD GLUCOSE WAS "92 MG/DL" PER THE LAB RESULTS AT 11:51 AM AS A BLOOD GLUCOSE READING OF "114 MG/DL" WAS OBTAINED AT 11:43 AM ON THE SURESTEP FLEXX METER USING A NEW VIAL OF TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSP SS FLEXX METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3055607004

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R