BEUDAMED
    FDA Adverse Event Death Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2380034 · Received December 16, 2011

    Report

    Report Number
    2939301-2011-12401
    Event Type
    Death
    Date Received
    December 16, 2011
    Date of Event
    November 20, 2011
    Report Date
    November 20, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 - CORRECTED DATA (B)(4) 2012. WITHIN THE INITIAL REPORT SUBMITTED ON (B)(6) 2011. THE COMPLAINT WAS BEING REPORTED BECAUSE THE PATIENT REPORTED SHE WAS UNABLE TO CHECK HER BLOOD GLUCOSE DUE TO RECEIVING ERROR MESSAGES AND THEN LATER DEVELOPED SYMPTOMS OF SEVERE HYPOGLYCEMIA, FROM WHICH SHE RECOVERED. THERE WAS NO EVIDENCE THAT THE ALLEGED ISSUES CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. PER THE DEATH CERTIFICATE THE PATIENT DIED OF A MYOCARDIAL INFARCTION.

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE THAT THE ALLEGED ISSUES CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH AS THE PATIENT DIED OF A MYOCARDIAL INFARCTION. THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(4) 2011, THE METER WAS TESTED AND NO FAULTS WERE FOUND. ON (B)(4) 2011, THE TEST STRIPS WERE TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED SINCE INCORRECT PRODUCTS WERE RETURNED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW UP #2 01/17/2012 - CORRECTION TO DEVICE EVALUATION SUBMITTED ON (B)(4) 2011 IN INITIAL REPORT. THE INITIAL REPORT INDICATED THAT "THE TEST STRIPS WERE TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED SINCE INCORRECT PRODUCTS WERE RETURNED." TO CLARIFY, THE REPORTER DID SEND BACK THE CORRECT TEST STRIPS WITH THE SUBJECT METER AND INVESTIGATIONS REVEALED THE FOLLOWING: ON (B)(4) 2011, THE METER WAS TESTED AND NO FAULTS WERE FOUND. ON (B)(4) 2011, THE SUBJECT TEST STRIPS WERE ALSO TESTED AND NO FAULTS WERE FOUND. IN ADDITION TO SENDING BACK CORRECT TEST STRIPS, NON-LFS PRODUCTS WERE ALSO SENT, ON WHICH NO TESTING WAS PERFORMED. UPDATED EVAL CODES TO REFLECT CORRECT DEVICE EVALUATION FINDINGS ALSO SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER WAS DISPLAYING AN 'ER5 & ER2'. PER THE ONETOUCH ULTRAMINI USER GUIDE, AN ERROR 5 INDICATES A PROBLEM WAS DETECTED WITH THE TEST STRIP SUCH AS DAMAGED TEST STRIP OR INCOMPLETELY FILLED CONFIRMATION WINDOW. AN ERROR 2 MESSAGE CAN BE CAUSED BY A USED TEST STRIP OR A PROBLEM WITH THE METER. ON (B)(6) 2011, THIS MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT'S SPOUSE, WHO ADVISED THE MSS THAT THE PATIENT PASSED AWAY ON (B)(6) 2011. THE COMPLAINT WAS CLASSIFIED BASED INFORMATION OBTAINED FROM THE SPOUSE AS WELL AS THE CONVERSATION BETWEEN THE PATIENT AND THE CUSTOMER CARE ADVOCATE (CCA) DURING THE INITIAL CALL. THE PATIENT CLAIMED THE ERROR MESSAGES BEGAN INTERMITTENTLY ON (B)(6) 2011. PER THE PATIENT, ON THE MORNING OF (B)(6) 2011, SHE ATTEMPTED TO CHECK HER BLOOD GLUCOSE WITH THE SUBJECT METER, BUT RECEIVED THE ERROR MESSAGES. SHE DENIED TAKING ANY ACTION AFTERWARDS. WITHIN 30 MINUTES OF ATTEMPTING TO TEST, SHE DEVELOPED SYMPTOMS OF ''CONFUSION, HEADACHE, SHAKING, NAUSEA AND WAS IRRITABLE AND SWEATING.'' HER SPOUSE CALLED EMERGENCY SERVICES WHO TESTED THE PATIENT WITH THEIR OWN (HCP) METER AND REPORTED A BLOOD GLUCOSE VALUE OF ''27MG/DL.'' THE PATIENT WAS TREATED WITH A GLUCAGON INJECTION AND GLUCOSE GEL. SHE WAS TAKEN TO THE ER. THE PATIENT WAS ALSO TREATED AT THE ER WITH FOOD. HER BLOOD GLUCOSE WAS RETESTED USING AN HCP METER AND A READING OF 82 MG/DL WAS OBTAINED. SHE WAS RELEASED FROM THE ER AT APPROXIMATELY 11:50AM THAT DAY. THE PATIENT STATED ON (B)(6) 2011 IN THE EVENING, SHE TESTED ON THE SUBJECT METER AND OBTAINED A READING OF ''518MG/DL.'' THE SPOUSE CONFIRMED THAT THE PATIENT RECEIVED REPLACEMENT PRODUCTS FROM LFS ON (B)(6) 2011, BUT DESPITE THIS, SHE CONTINUED TO USE THE SUBJECT METER AND TEST STRIPS BECAUSE SHE GOT THEM TO WORK. THE SPOUSE COULD NOT CONFIRM IF THE PATIENT CONTINUED TO OBTAIN THE INTERMITTENT ERROR MESSAGES. THE SPOUSE REPORTED THAT ON (B)(6) 2011 AT APPROXIMATELY 9:50AM, HE LEFT FOR CHURCH. DURING THIS TIME, THE PATIENT WAS IN AND OUT OF SLEEP BUT DID NOT APPEAR TO BE ILL. HE STATED THAT HE RETURNED AT APPROXIMATELY 11:40AM AND FOUND THE PATIENT HAD PASSED AWAY IN HER SLEEP. HER BLOOD GLUCOSE WAS LAST TESTED WITH THE SUBJECT METER ON (B)(6) 2011 AT 11:22PM (BLOOD GLUCOSE '128 MG/DL'). THE SPOUSE STATED HE GAVE HER USUAL SNACKS (CHIPS, CHEESE AND SODA) BEFORE SHE WENT TO SLEEP THAT NIGHT. THE CAUSE OF DEATH AS STATED ON THE PATIENT'S DEATH CERTIFICATE WAS ''MYOCARDIAL INFARCTION'' DUE TO ''CORONARY ARTERY DISEASE.'' THE PATIENT'S SPOUSE INFORMED THE MSS THAT THE PATIENT WAS A BRITTLE DIABETIC. THE PATIENT'S BLOOD GLUCOSE OFTEN SPIKED IN THE EVENINGS AND DROPPED LOW BY THE MORNING. SHE HAD BEEN SUFFERING FROM NUMEROUS CHRONIC MEDICAL PROBLEMS INCLUDING RENAL FAILURE, EDEMA AND MIGRAINES. SHE WAS TAKING MEDICATIONS FOR OTHER CHRONIC MEDICAL PROBLEMS FOR THE PAST 3 YEARS. SHE TESTED HER BLOOD GLUCOSE 3X DAILY AND MANAGED HER DIABETES WITH SYMLIN (DOSE UNKNOWN) AND HUMULIN INSULIN BASED ON A SLIDING SCALE AT MEAL TIMES. THE PATIENT'S SPOUSE STATED HER ROUTINE WAS NOT CONSISTENT; SHE REPORTEDLY TESTED EARLY IN THE MORNING, WOULD GO BACK TO SLEEP AND HAVE HER FIRST MEAL BETWEEN 12-2PM AND TOOK HER INSULIN PRIOR TO HER LUNCH AND DINNER. THE PATIENT WAS USING THE CORRECT TEST STRIPS PERFORMED BLOOD GLUCOSE TESTING CORRECTLY. DURING THE INITIAL CALL WITH THE CCA, THE PATIENT WAS ABLE TO SUCCESSFULLY OBTAIN A BLOOD GLUCOSE RESULT OF '96MG/DL' WITH THE SUBJECT PRODUCTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTED THE PATIENT WAS UNABLE TO CHECK HER BLOOD GLUCOSE DUE TO RECEIVING ERROR MESSAGES AND THEN LATER DEVELOPED SYMPTOMS OF SEVERE HYPOGLYCEMIA AS WELL AS A BLOOD GLUCOSE ABOVE 500 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3174310

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| L| R