TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - FREE METER ONLY (REF RE4011-00)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00087701426520), received between Nov 22, 2016 and Jan 17, 2019 — classified as 23 malfunctions.

The most frequently reported specific device problem is “High Test Results” (15 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI, 343, 376, 397, 379, 537 AND 469 MG/DL. THE CUSTOMER DOES NOT KNOW WHAT HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS. 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) 2018, 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 03/26/2020, AND CUSTOMER STATED TEST STRIPS WERE OPENED RECENTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8258321 ↗
• MalfunctionOct 8, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR E-0 AND HI DISPLAY. 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 IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE LIVING ROOM; HOWEVER CUSTOMER WAS PUTTING SOME STRIPS IN CARRYING CASE FROM THE ORIGINAL VIAL. CUSTOMER WAS TESTING WITH TEST STRIPS THAT WERE BEEN OUTSIDE OF THE VIAL FOR A LONG PERIOD OF TIME. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF E-0 AND HI USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/29/2020 AND OPEN VIAL DATE WAS ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). CUSTOMER CALLED IN STATES THE METER IS READING HI DISPLAY. CUSTOMER CALLED IN WITH E-0 AND OBTAINED HI. CUSTOMER IS NOT CONCERNED WITH OTHER READINGS. CUSTOMER DOES NOT HAVE AN EXPECTED RANGE. CUSTOMER WAS PUTTING SOME STRIPS IN CARRYING CASE BUT STORING STRIPS IN LIVING ROOM AREA. CUSTOMER TESTED FROM THE OPEN VIAL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7943194 ↗
• MalfunctionSep 10, 2018Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem; Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR E-5 ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING DIZZY, BLURRED VISION, FREQUENT URINATION, FATIGUE AND THIRST. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED DURING THE CALL ON (B)(4) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF E-5 TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2019 AND OPEN VIAL DATE IS DATE. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. WHILE TROUBLESHOOTING THE ERROR MESSAGE DID APPEAR AGAIN.

  Patient problems: Blurred Vision; Dizziness; Urinary Frequency / Polyuria

  MAUDE report 7862489 ↗
• MalfunctionJun 25, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 85, 82 AND 98 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 - 140 MG/DL. CUSTOMER WAS NOT USING CORRECT TESTING TECHNIQUE AS HE WAS USING ALCOHOL TO CLEAN HIS FINGERS. 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) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AN IS STORED ABOVE THE REFRIGERATOR IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/24/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7634418 ↗
• MalfunctionJun 7, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF E-5 AND HI. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 300MG/DL. 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 IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE LIVING ROOM. DURING THE CALL ON 05/15/2018, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF E-5 USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/25/2019 AND OPEN VIAL DATE IS TWO WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLING STATES THAT THE METER IS GIVING THE E-5 ERROR. CUSTOMER RUN SEVERAL TEST AND SHE IS ONLY GETTING THE E-5 ERROR. CUSTOMER STATES THAT SHE THEN USE HER OTHER METER AND RUN A BLOOD TEST AND GOT 577MG/DL FASTING. CUSTOMER ALSO GOT A HI RESULT ON THE METER. I EXPLAIN TO CUSTOMER WHAT THE E-5 ERROR MEANS AND WHY IT MAY OCCUR. CUSTOMER STATES THAT HER NORMAL GLUCOSE RANGE IS 300MG/DL FASTING. CUSTOMER HAVE BEEN TAKING PREDNISONE STEROIDS AND KNOW THAT HER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7578235 ↗
• MalfunctionApr 18, 2018Low Test Results; Device Displays Incorrect Message; Low Test Results; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULT OF 49 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 140 MG/DL. DAUGHTER STATED THAT WHEN CUSTOMER OBTAINED THE RESULT OF 49 MG/DL FASTING SHE WAS HAVING SYMPTOMS (EXACT SYMPTOMS UNDISCLOSED); CUSTOMER HAD DRANK ORANGE JUICE TO BRING HER BLOOD SUGAR UP. CUSTOMER WAS ALSO OBTAINING A LOT OF ERROR MESSAGES PRIOR TO OBTAINING THAT RESULT. AT THE TIME OF THE CALL THE CUSTOMER FELT 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) 2018, 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 01/20/2019 AND OPEN VIAL DATE IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER IS NOT CONCERNED WITH THE RESULTS OF 65 AND 69 MG/DL): RESULT 1:69MG/DL DATE: (B)(6) 2018 TIME:840AM FASTING; RESULT 2:65MG/DL DATE: (B)(6) 2018 TIME:8:39AM FASTING; R

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7439844 ↗
• MalfunctionMar 16, 2018High 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 173 AND 182 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 150 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) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER; CUSTOMER WAS NOT FASTING AT TIME OF CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7344988 ↗
• MalfunctionMar 6, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER ALSO CONCERNED THAT RESULTS ARE ERRATIC AND HIGH. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 97, 122 AND 84 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 125 - 150 MG/DL. CUSTOMER SAYS METER ALSO TURNS ON AND OFF BY ITSELF. 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) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 125 MG/DL AND 129 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/21/2018 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7318334 ↗
• MalfunctionJan 4, 2018High Test Results; High Test Results

  CONSUMER INITIALLY REPORTED COMPLAINT FOR E-3 ERROR. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 150 MG/DL AND 180 MG/DL USING TRUEMETRIX METER. CUSTOMER STATED THE RESULTS WERE TOO HIGH. THE CUSTOMER IS ALSO CONCERNED WITH TEST RESULTS FROM METER MEMORY OF 153 AND 144 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 110 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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2018 AND OPEN VIAL DATE AT TIME OF CALL IS THREE WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED ABOUT E-3 ERROR MESSAGES, OBTAINED A RESULTS OF 150 MG/DL FASTING, CUSTOMER STATES THAT RESULTS WAS TOO HIGH, PERFORMED A SECOND TEST AND RESULTS WERE 180 MG/DL. CUSTOMER'S EXPECTED RANGE FASTING IS 90-110 MG. CUSTOMER STATES HE IS CONCERNED THAT THE RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7165975 ↗
• MalfunctionNov 10, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS.THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 110MG/DL. 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 IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. 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 201 AND 209MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT1:203MG/DL DATE:(B)(6) 2017 TIME:4:55PM FASTING, RESULT2 : 210MG/DL DATE:(B)(6) 2017 TIME:5:00PM FASTING, RESULT3 : 214MG/DL DATE:(B)(6) 2017 TIME:5:15PM FASTING, RESULT4 :206MG/DL DATE:(B)(6) 2017 TIME:5:20PM FASTING, RESULT5 : 244MG/DL DATE:(B)(6) 2017 TIME:5:35PM FASTING. CUSTOMER IS CONCERNED WITH ALL RESULTS LISTED. CUSTOMER STATES SHE ACCIDENTLY DROPPED HER METER AND THINKS HER METER IS NOW GIVING HER HIGH RESULTS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7017986 ↗
• MalfunctionAug 15, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. BROTHER IN LAW IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH THE NON-FASTING RESULT OF 580MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF "NOT FEELING WELL". MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2018 AND OPEN VIAL DATE IS 07/23/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). ON (B)(6) 2017 CUSTOMER HAD BLOOD GLUCOSE READING OF 35MG/DL. HE DECIDED TO INTAKE SUGAR CONCENTRATED FOODS TO ELEVATE BLOOD SUGAR. THEN, ON (B)(6) 2017 HIS BLOOD SUGAR WAS 580 MG/ NON FASTING. BROTHER IN LAW SAID CUSTOMER IS NOT FEELING WELL AND THE BROTHER IN LAW DID NOT KNOW WHAT TO DO. THEREFORE, THE 911 WAS CALLED. CUSTOMER REP HAD TO CALL 911 TO HAVE CUSTOMER CHECKED SINCE NO ONE KNEW HIS STATUS. HOWEVER, CUSTOMER REFUSED TO GO TO THE HOSPITAL AND REFUSED TO HAVE BLOOD SUGAR TAKEN BY AMBULANCE (DUE TO A SCHEDULED BINGO GAME). WILL FOLLOW U

  Patient problems: No Code Available

  MAUDE report 6795853 ↗
• MalfunctionMay 8, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 46MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/20/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). CUSTOMER CALLED REGARDING LOW RESULTS; CUSTOMER DENIED HYPOGLYCEMIA SYMPTOMS. CUSTOMER DENIES ANY NEED OF MEDICAL CARE. NO CHANGES IN EXERCISE, DIET OR MEDICATION. CUSTOMER STATED HGA1C- 6.9.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6552335 ↗
• MalfunctionApr 20, 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 227, 202, 235 AND 296 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 TO 160MG/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. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 180 AND 217MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). THE CUSTOMER IS COMPARING HIS RESULTS TO WHAT HE USED TO GET ON HIS TRUE TRACK METER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6509172 ↗
• MalfunctionMar 27, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-0 ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF E-0 AND SYMPTOM. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER REPORTED SYMPTOM OF FEELING TIRED. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER STATE THAT SHE IS FEELING TIRED. CUSTOMER DAUGHTER STATES THAT SHE IS HAVING ISSUES WITH HER HEMOGLOBIN AND HER HEMOGLOBIN IS POSSIBLY LOW. SHE WILL TAKE HER THE TO THE DR. RIGHT NOW. UNABLE TO MAKE CONTACT WITH CUSTOMER AFTER 3 ATTEMPTS.

  Patient problems: No Code Available

  MAUDE report 6435903 ↗
• MalfunctionFeb 21, 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 210, 244 AND 175 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 140 MG/DL. DURING THE CALL ON (B)(6) 2017, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER STATED HE OBTAINED A READING ON (B)(6) 2017 AT 5:59 AM OF 175 MG/DL FASTING WHILE HE WAS EXPERIENCING SYMPTOMS OF LOW BLOOD SUGAR; LIGHTHEADED. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2018 AND OPEN VIAL DATE AT TIME OF CALL IS TWO WEEKS. THE CUSTOMER STATED HAS NOT HAD ANY RECENT CHANGES IN HIS DAILY ROUTINE AND MANAGES HIS DIABETES WITH DIET AND EXERCISE. THE CUSTOMER STATED HE IS NOT CONCERNED WITH THE 268 MG/DL READING AS IT WAS NON-FASTING. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS:199MG/DL, 210MG/DL, 244MG/DL, 175MG/DL.

  Patient problems: No Code Available

  MAUDE report 6347485 ↗
• MalfunctionFeb 17, 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 276, 283 AND 312 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 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 FASTING AND PRODUCED TEST RESULTS OF 316 MG/DL AND 344 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/23/2017 AND OPEN VIAL DATE IS (B)(6) 2017. CUSTOMER STATED HE DOES NOT TAKE ANY MEDICATIONS AND THAT HE HAS NOT HAD ANY CHANGES IN HIS DIET OR EXERCISE. CUSTOMER STATED HE TAKES HIS BLOOD TEST FASTING. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6341302 ↗
• MalfunctionJan 20, 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 197 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85 TO 95 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 01/20/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER MONITORS HIS DIET CLOSELY AND JOURNALS HIS MEAL. CUSTOMER STATES THAT HE IS ONLY PRE- DIABETIC AND HAS NEVER HAD THAT HIGH OF A NUMBER IN HIS LIFE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6266082 ↗
• MalfunctionDec 30, 2016High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200 TO 400MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. 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 PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF E-5 AND 577MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/303/2017 AND OPEN VIAL DATE IS 12/01/2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: THE 194MG/DL (B)(6) 2016 10:37 PM FASTING: YES, THE 187MG/DL (B)(6) 2016 05:00 PM FASTING: YES, THE 540MG/DL (B)(6) 2016 01:53 PM FASTING: NO, THE 597MG/DL (B)(6) 2016 12:58 PM FASTING: NO, THE 126MG/DL (B)(6) 2016 10:19 PM FASTING: YES. CUSTOMER CALLED IN STATING HE WAS GETTING E-5 MESSAGES, HOWEVER CUSTOMER ALSO MENTIONED HE HAD RECEIVED THE READING OF HI A COUPLE OF DAYS AGO. CUSTOMER STATES HE DOES NOT RECALL IF THE HI READING WAS FASTING OR NON-F

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6215516 ↗
• MalfunctionDec 29, 2016High Test Results; High Test Results

  CUSTOMER SENT AN EMAIL 12/4/16 WHICH STATES, "I HAVE A METER THAT I THINK IS GIVING ME A FALSE READING. IT SEEMS TO BE READING HI. THE OTHER DAY IT WAS 243 IN THE AM AND I TOOK 45 UNITS NPH N WHICH I TAKE EVERY MORNING ATE SMALL ORANGE AND YOGURT SHORT TIME LATTER BECOME DIZZY WHET TO ER THEY TOOK MY BLOOD SUGAR IT WAS ONLY 70 I THINK IT HAS BEEN READING WRONG LATELY IS THEIR SOMEWAY I CAN CHECK TO MAKE SURE IT IS ACCURATE?" AN EMAIL RESPONSE WAS SENT TO THE CUSTOMER APOLOGIZING FOR THE INCONVENIENCE AND REQUESTING A CALL BACK DUE TO A PHONE NUMBER NOT BEING PROVIDED. CUSTOMER CALLED ON (B)(6) 2016 REGARDING CONCERN WITH RESULTS AND TO FIND OUT CUSTOMER'S CONDITION, WITH NO ANSWER. METER INFORMATION WAS OBTAINED WHEN CUSTOMER CALLED IN AND LEFT A MESSAGE.

  Patient problems: Dizziness

  MAUDE report 6212655 ↗
• MalfunctionDec 23, 2016High 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 227 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 152 MG/DL. THE CUSTOMER STATED THAT TRUEMETRIX METER IS READING UP TO 50 MG/DL HIGHER THAN BOTH HIS ONETOUCH AND CONTOUR METER. THE CUSTOMER STATED THAT HE DID NOT KNOW THE RESULTS THE CONTOUR AND ONETOUCH WERE GIVING BUT HE KNOWS THAT THE TWO WERE WITHIN 2-3 MG/DL OF EACH OTHER WHEN THE TRUEMETRIX WAS ABOUT 50 MG/DL HIGHER. THE CUSTOMER STATED HE NO LONGER HAS STRIPS FOR HIS OTHER METERS SO HE WILL NOT BE COMPARING METERS. 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 11/29/2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED IN THE DINING ROOM NEAR THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/28/2017 AND OPEN VIAL DATE AT TIME OF CALL IS A LITTLE OVER A MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6202121 ↗
• MalfunctionDec 16, 2016High Test Results; High Test Results

  COSTUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS OF 600MG/DL. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 600MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 160-180MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS ON (B)(6) 2016. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS (B)(6) 2016 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED IN AND LEFT MESSAGE STATING METER WAS READING 600MG/DL AND SHE WAS GOING TO GET METER REPLACED AT LOCAL PHARMACY. CALLED CUSTOMER BACK, UNABLE TO ESTABLISH CONTACT WITH CUSTOMER, LEFT VOICEMAIL WITH CONTACT INFORMATION. CALLED LOCAL PHARMACY TO SEE IF CUSTOMER HAD PICKED UP A NEW METER AND STRIPS. PHARMACIST, (B)(6), STATED CUSTOMER DID PICK UP NEW METER AND STRIPS AND CUSTOMER DID LEAVE A METER AND A VIAL OF STRIPS. OBTAINED READINGS FROM MEMORY THROUGH PHARMACIST WHO WENT THROUGH MEMORY. WILL SEND OUT REPLACEMENT METER AND STRIPS TO PHARMACY AND WILL ALSO SEND PREPAID ENVELOPE FOR PHARMACY TO RETURN ALLEGEDLY DEFE

  Patient problems: Hyperglycemia

  MAUDE report 6182919 ↗
• MalfunctionDec 2, 2016Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR, THE E-5 IS A TEST STRIP ERROR, THAT COULD MEANS CUSTOMER MAY HAVE VERY HIGH BLOOD GLUCOSE RESULT. THE E-5 OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 120 MG/DL. DURING THE CALL ON (B)(6) 2016, THE CUSTOMER STATED THAT KNEW THE BLOOD SUGAR LEVELS WERE HIGH AS CUSTOMER HAD SYMPTOMS OF DRY MOUTH, FATIGUE, THIRST, BLURRED VISION AND FREQUENT URINATION. CUSTOMER WAS ADVISED TO SEEK MEDICAL ATTENTION BUT DECLINED. DURING THE CALL ON (B)(6) 2016, THE CUSTOMER PERFORMED A BLOOD TEST THAT PRODUCED RESULT OF E-5 NEWLY; CUSTOMER THEN OPENED UP ANOTHER BOX OF THE SAME LOT NUMBER OF STRIPS AND ATTEMPTED A RETEST AND RECEIVED A RESULT OF E-5 AGAIN. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/25/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6). THE CUSTOMER HAD NOT MADE ANY RECENT CHANGES TO DIET OR MEDICATION.

  Patient problems: Blurred Vision; Fatigue; Urinary Frequency / Polyuria

  MAUDE report 6141943 ↗
• MalfunctionNov 22, 2016Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 95 TO 105 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 PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 91 AND 90 MG/DL. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6122431 ↗