TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - FREE METER ONLY (REF RE4054-00)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00010939722447), received between Jan 9, 2017 and Jun 19, 2018 — classified as 13 malfunctions.

The most frequently reported specific device problem is “High Test Results” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-2 ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOM OF FEELING SICK. CUSTOMER CAN'T DESCRIBE THE SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND SYMPTOMS. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY CUSTOMER AND PRODUCED TEST RESULTS OF 249MG/DL USING TRUE METRIX METER. THE PRODUCT IS NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/22/2019 AND OPEN VIAL DATE IS UNKNOWN. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. DURING THE CALL METER READ THE BLOOD 249MG/DL. CUSTOMER DOES NOT KNOW IF THIS IS A GOOD NUMBER FOR HER OR NOT. CUSTOMER WAS ADVISED TO SPEAK TO HER DOCTOR ABOUT HER GLUCOSE READINGS AND ADVISED TO CALL 911 OR HER DOCTOR IF HER SYMPTOMS PERSIST.

  Patient problems: No Information

  MAUDE report 7616022 ↗
• MalfunctionMar 1, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 300 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 180 MG/DL. THE CUSTOMER FEELS WELL AT TIME OF CALL AND DID REPORT PRIOR SYMPTOMS OF FEELING FAINT AND DIZZY. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/17/2019 AND OPEN VIAL DATE IS APPROXIMATELY THREE WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). CUSTOMER GOT SOME WRONG RESULTS YESTERDAY. CUSTOMER STATES THAT SHE RAN A BLOOD TEST AND GOT RESULT OF 300 MG/DL FASTING. SHE TOOK SOME MEDICINE AND THEN HER GLUCOSE DROP TOO LOW. CUSTOMER STATES THAT SHE STARTED TO FEEL DIZZY AND ABOUT TO FAINT, UNABLE TO WALK/ WOBBLING. SHE THEN GOT SOMETHING TO EAT AND THE RESULT CAME UP. CUSTOMER STATES THAT HER GLUCOSE DROP LOW BECAUSE SHE TOOK THE MEDICATION BASE ON THE RESULTS THE METER WAS GIVEN AND THEN HER SUGAR D

  Patient problems: Dizziness

  MAUDE report 7306698 ↗
• MalfunctionJan 12, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 162, 184, 149 AND 198 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-140MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/19/2018 AND OPEN VIAL DATE AT TIME OF CALL IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :162MG/DL DATE: (B)(6) 2017 TIME:7:38AM FASTING , RESULT 2 :184MG/DL DATE: (B)(6) 2017 TIME:7:47AM FASTING , RESULT 3 :107MG/DL DATE: (B)(6) 2017 TIME:7:47PM FASTING , RESULT 4 :149MG/DL DATE: (B)(6) 2017 TIME:1:08PM FASTING , RESULT 5 :198MG/DL DATE: (B)(6) 2017 TIME:6:37AM FASTING . CUSTOMER STATES THAT HE HAS BEEN A DIABETIC FOR A LONG TIME AND KNOWS THAT HIS RESULTS SHOULD NOT BE HIGHER THAN 140MG/DL FASTING. CUSTOMER IS CONCERNED THAT THE METER IS GIVING HIGH RESU

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7186307 ↗
• MalfunctionDec 15, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER'S AID IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 600, 549, 411, 345 AND 327MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 98 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. AIDE STATED WHEN THE CUSTOMER OBTAINED THE HIGH RESULTS SHE WAS NOT HAVING ANY DIABETIC SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE CUSTOMER DECLINED TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL ON (B)(6) 2017. PER CUSTOMER, THE BARREL OF HER LANCING DEVICE IS BROKEN. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM.THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/24/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :600MG/DL DATE:(B)(6) TIME:11:20AM FASTING, RESULT 2 :549MG/DL DATE:(B)(6) TIME:12:00PM FASTING, RESULT 3 :411MG/DL DATE:(B)(6) TIME:10:50AM FASTING, RESULT 4 :345MG/DL DATE:(B)(6) TIME:8:20PM FASTING, RESULT 5 :327MG/DL DATE:(B)(6) TIME:2:00PM FASTING. CUSTOMER STATES RESULTS ARE HIGH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7121232 ↗
• MalfunctionNov 30, 2017Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR METER NOT GOING TO TEST MODE ACCOMPANIED BY SYMPTOMS. (B)(6), SON, IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH SYMPTOMS AND METER NOT GOING TO TEST MODE.THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. CUSTOMER IS FEELING WEAK AND THINK IT IS BECAUSE OF HIS DIABETES. CUSTOMER WAS IN THE HOSPITAL BECAUSE HIS BLOOD GLUCOSE LEVELS WERE TOO HIGH. CUSTOMER HAS NOT BEEN TESTING AND WENT TO THE HOSPITAL BECAUSE OF HIGH BLOOD RESULTS. CUSTOMER RESULTS IN THE HOSPITAL WAS 600MG/DL. (B)(6) (SON) WAS GIVEN THIS METER FOR HIM TO START MONITOR HIS BLOOD SUGAR (HE WAS ALSO GIVEN INSULIN). CUSTOMER GOT OUT OF THE HOSPITAL ON (B)(6) 2017. CUSTOMER JUST GOT THIS METER AND NEEDS TO USE IT TO TEST. CUSTOMER IS FEELING WEAK. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 213MG/DL USING TRUE METRIX METER. CUSTOMER WAS PERFORMING THE BLOOD GLUCOSE TEST WRONG BY PUTTING THE BLOOD SAMPLE ON TOP OF THE TEST STRIP. COMPLAINT RESOLVED BY TRAINNING AT THE TIME OF THE CALL. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/

  Patient problems: Weakness

  MAUDE report 7070961 ↗
• MalfunctionOct 18, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI READING. HOME HEALTH CARE NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED RESULTS OF HI. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNKNOWN. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS.. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF HI AND HI USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 6/21/2018 AND OPEN VIAL DATE IS APPROXIMATELY TWO WEEKS AGO. CUSTOMER IS NOT CONCERNED WITH LOW RESULTS. (B)(6). THE HHN RAN THE BLOOD TWICE ON THE CUSTOMER WITH NO SYMPTOMS AND IS GETTING HI ON BOTH RESULTS. HHN DID NOT HAVE ANOTHER METER TO CHECK HER BLOOD AND NO CONTROL SOLUTION. HHN WAS THERE TO DO A FOLLOW UP ON THE CUSTOMER WITH NO SYMPTOMS AT ALL. HHN SAID THIS METER LOOKS VERY OLD AND SHE IS NOT SURE THE CARE OF THIS METER. SHE ALSO ADDED THE LANCING DEVICE IS NOT ARMING ANY MORE. THE HHN WILL CALL THE DAUGHTER JUST TO LET HER KNOW WHAT IS HAPPENING BUT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6959589 ↗
• MalfunctionJun 29, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 226 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 118 - 120 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/14/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: THE 226MG/DL (B)(6) 2017 03:01 AM FASTING: YES, THE 226MG/DL (B)(6) 2017 02:32 AM FASTING: YES, THE 215MG/DL (B)(6) 2017 02:08 AM FASTING: YES, THE 189MG/DL (B)(6) 2017 02:07 AM FASTING: YES, THE 167MG/DL (B)(6) 2017 07:10 AM FASTING: YES. MEMORY CONCERNS: CUSTOMER IS CONCERN WITH ALL THESE RESULTS CUSTOMER STATES THAT THE METER IS GIVING HER HIGH BLOOD RESULTS. CUSTOMER STATES THAT SHE HAVE BEEN A DIABETIC SINCE 2002 AND NEVER HAD THESE HIGH BLOOD RESULTS BEFORE. CUSTOMER STATE THAT NO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6676724 ↗
• MalfunctionJun 23, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 198, 435 AND 200 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 240 MG/DL USING TRUEMETRIX METER AND 224 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/18/2018 AND OPEN VIAL DATE AT TIME OF CALL IS THREE WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). MEMORY CONCERNS:CUSTOMERS DAUGHTER IS CONCERNED WITH THE RESULTS OF 198, 435, 200, 241 AND 203 MG/DL IN THE METERS MEMORY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6665319 ↗
• MalfunctionMar 30, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-0 ERROR: INVALID HEMATOCRIT. THE ERROR OCCURRED WITH MULTIPLE STRIPS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. DURING THE CALL ON (B)(6) 2017, THE CUSTOMER STATED HE WAS CRAMPING AND BELIEVED IT WAS BECAUSE HIS BLOOD SUGAR WAS HIGH. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 83 MG/DL USING TRUEMETRIX METER. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/21/2018 AND OPEN VIAL DATE AT TIME OF CALL WAS ONE WEEK. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Cramp(s)

  MAUDE report 6445890 ↗
• MalfunctionFeb 27, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 130 MG/DL; CUSTOMER TESTS THREE TIMES A DAY. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. WIFE HAD STATED THE CUSTOMER HAD GONE TO THE DOCTOR'S OFFICE BECAUSE THEY WERE CONCERNED WITH THE HIGH RESULTS, AND ALSO BECAUSE THEY WERE GETTING A LOT OF ERRORS WITH THE METER. WIFE STATED CUSTOMER WAS NOT HAVING ANY SYMPTOMS AND DID NOT NEED NEEDED ANY MEDICAL ATTENTION AT THE TIME, CUSTOMER WAS JUST CONCERNED. WIFE STATED THAT THE DOCTOR RAN A LAB TEST AND THAT THE RESULTS WERE GOOD, THEY WERE THE SAME AS THE PREVIOUS LAB RESULTS. WIFE STATED THAT THE DOCTOR DID NOT THINK THERE IS ANYTHING TO WORRY ABOUT. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE CUSTOMER IS ON INSULIN. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6360679 ↗
• MalfunctionJan 30, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 224 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 175 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/23/2017 AND OPEN VIAL DATE IS APPROXIMATELY ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED IN STATING THAT HIS RESULTS HAVE BEEN AT LEAST 60 POINTS HIGHER THAN WHAT HIS NORMAL RESULTS RUN. CUSTOMER STATES HE USUALLY NEVER RUNS OVER 175 MG/DL WHILE FASTING IN THE MORNING. CUSTOMER STATES THAT HIS RESULTS TEND TO RUN LOWER IN THE EVENINGS WHEN HE TESTS. CUSTOMER STATES HE MONITORS WHAT HE EATS AND HAVE A FAMILY HISTORY OF DIABETES. CUSTOMER STATES HE IS NOT SURE OF THE YEAR SET IN THE MONITOR BECAUSE THE DATE AND TIME ARE INCORRECT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6286183 ↗
• MalfunctionJan 20, 2017Incorrect Or Inadequate Test Results; High Test Results; Incorrect Or Inadequate Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER STATED THAT THE METER WAS ALSO GIVING HIGH READINGS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TESTS USING TRUEMETRIX METER OF 197 AND 234 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 130 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2016, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2017 AND OPEN VIAL DATE AT TIME OF CALL IS ABOUT A MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: 197 234 162 161 191MG/DL CUSTOMER IS CALLING CONCERNED THAT HIS METER IS GIVING BOTH ERRATIC AND HIGH READINGS. CUSTOMER DID A BACK TO BACK FASTING TEST ON THE SAME HANDS, DIFFERENT FINGERS AND OBTAINED A 234MG/DL THEN A 197MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6266682 ↗
• MalfunctionJan 9, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 322MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 140MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE BATHROOM. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/23/2017 AND OPEN VIAL DATE IS APPROXIMATELY ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). FOLLOW UP CALL MADE TO THE CUSTOMER IN REGARD TO AN E-0 ERROR. AFTER TROUBLESHOOTING CUSTOMER OBTAINED A HIGH RESULT OF 322MG/DL. CUSTOMER WASN'T SATISFIED WITH ERRORS AND WENT TO LOCAL PHARMACY TODAY AND WAS GIVEN ANOTHER TRUE METRIX METER. CUSTOMER TESTED WITH NEW METER AND OBTAINED 256MG/DL WHICH IS CLOSE TO HIS FASTING RESULT OF 266MG.DL OBTAINED FASTING THIS MORNING WITH ANOTHER DEVICE. CUSTOMER FELT COMFORTABLE WITH RESULTS FROM NEW METER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6234229 ↗