TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - NOT FOR RETAIL SALE (REF RE4H01-43)Recalls & reported problems

Summary

The FDA's MAUDE database contains 418 adverse event reports that list this exact device (DI 00021292006075), received between Nov 21, 2016 and Mar 25, 2021 — classified as 13 injuries, 405 malfunctions.

The most frequently reported specific device problem is “High Test Results” (252 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 25 most recent of 418 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2021Battery Problem; Battery Problem

  CONSUMER REPORTED COMPLAINT FOR BATTERY PROBLEM, STATING THAT THE TRUE METRIX METER WAS POWERING ON AND THEN SHUTTING OFF. CUSTOMER STATED THE BATTERY HAD BEEN CHANGED OVER THREE YEARS AGO. DURING THE CALL THE TRUE METRIX METER POWERED ON USING THE POWER BUTTON AND WHEN A TEST STRIP WAS INSERTED; THE "LOW BATTERY" SYMBOL WAS ON. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED SHE HAD CALLED THE AMBULANCE THE NIGHT BEFORE; CUSTOMER STATED SHE HAD FELT LIGHTHEADED AND WAS SWEATING. CUSTOMER STATED SHE TESTED AND OBTAINED A BLOOD GLUCOSE TEST RESULT OF 53MG/DL FASTING ABOUT 2 1/2 HOURS AFTER HER DINNER ABOUT 9 PM. CUSTOMER HAD CALLED THE AMBULANCE AND STATED THAT SHE DRANK A (B)(6). WHEN THE EMT'S HAD ARRIVED THEY HAD PERFORMED A BLOOD GLUCOSE TEST AND OBTAINED A RESULT OF 126MG/DL. THE DIAGNOSIS HAD BEEN LOW BLOOD SUGAR. CUSTOMER HAD DECLINED GOING TO THE HOSPITAL. CUSTOMER DID NOT RECEIVE ANY MEDICAL TREATMENT AND WAS ADVISED TO CONTINUE TO MONITOR BLOOD SUGAR. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/20/2022 AND OPEN VIAL DATE IS UNDISCLOSED.

  Patient problems: Hypoglycemia; Syncope/Fainting

  MAUDE report 11567641 ↗
• MalfunctionFeb 2, 2021Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR DEFECTIVE LCD DISPLAY. CUSTOMER REPORTED THE NUMBERS DISPLAYED PARTIAL CHARACTERS AND THAT THEY WERE BLURRY. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED HAD TAKEN HIS METFORMIN MEDICATION BASED ON RESULTS DISPLAYED. CUSTOMER STATED HE HAD TAKEN THE MEDICATION AS PRESCRIBED BY HIS DOCTOR, WHETHER HE CAN SEE THE TEST RESULT OR NOT. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11267680 ↗
• MalfunctionFeb 2, 2021Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR DEFECTIVE LCD DISPLAY, STATING THE TRUEMETRIX METER DISPLAYED PARTIAL NUMBERS. CUSTOMER STATED HE OBTAINED A RESULT OF "137 MG/DL FASTING" BUT WAS UNSURE IF IT WAS "187 MG/DL" AND THAT HE HAD ADMINISTERED 30 UNITS OF INSULIN. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. DURING THE CALL, THE CUSTOMER TURNED THE TRUEMETRIX METER ON AND STATED THAT WHEN THE SCREEN CAME ON, THE 888'S WERE SHOWING PARTIAL NUMBERS. CUSTOMER'S TEST STRIPS ARE EXPIRED; MANUFACTURER¿S EXPIRATION DATE IS 02/21/2020. CUSTOMER ADVISED THAT THE TRUEMETRIX METER HAS NEVER BEEN DROPPED OR MISHANDLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11265838 ↗
• MalfunctionJan 25, 2021High Test Results; High Test Results

  CONSUMER INITIALLY CALLED FOR TRAINING ON PERFORMING A BLOOD TEST SINCE NEW USING THE PRODUCT. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF HI USING THE METER. THE CUSTOMER¿S EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT IS IN THE 200'S MG/DL (EXACT RESULT NOT PROVIDED). THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE BLOOD GLUCOSE TEST RESULTS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (STORED IN THE KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/31/2022 AND OPEN VIAL DATE IS 12/29/2020. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11226936 ↗
• MalfunctionDec 31, 2020High 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 384, 326, 307, 303 AND 320 MG/DL. CUSTOMER STATED THESE HIGH RESULTS STARTED WITHIN THE PAST TWO WEEKS. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150-220 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, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 271 MG/DL USING THE METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/15/2022 AND OPEN VIAL DATE IS (B)(6) 2020. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11100551 ↗
• InjuryDec 18, 2020Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 372, 348 AND 500 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110-175MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION WAS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING AREA. DURING THE CALL A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/31/2022 AND OPEN VIAL DATE IS ONE TO TWO WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11037650 ↗
• MalfunctionNov 9, 2020Low Test Results; Device Displays Incorrect Message; Low Test Results; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 77MG/DL. THE EXPECTED NON- FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 127-134MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. DURING THE CALL A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 77MG/DL NON-FASTING USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/12/2020 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10809592 ↗
• InjuryNov 6, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 231MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF DIARRHEA NS STOMACH PAIN. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 231MG/DL FASTING USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/31/2021 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Abdominal Pain

  MAUDE report 10802735 ↗
• InjuryNov 4, 2020Failure to Power Up; Failure to Power Up

  CONSUMER REPORTED COMPLAINT FOR DEAD METER. BLOOD GLUCOSE TEST RESULTS. HAYWORD/NURSE/LOCAL CLINIC IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/20/2021 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10787868 ↗
• MalfunctionOct 16, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 ERROR. CUSTOMER STATED THAT HE HAS HAD THE TRUEMETRIX METER FOR SEVERAL YEARS. CUSTOMER WAS USING THE PROPER TESTING TECHNIQUE. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 130 MG/DL USING TRUEMETRIX METER. CUSTOMER WAS SATISFIED WITH THE RESULT OBTAINED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT HE HAD BEEN HOSPITALIZED TWO MONTHS AGO DUE TO HYPERGLYCEMIA AND LOW BLOOD PRESSURE. CUSTOMER DID NOT DISCLOSE WHY HE HAD SOUGHT MEDICAL INTERVENTION. CUSTOMER STATED THAT HIS BLOOD GLUCOSE TEST RESULT WHEN ADMITTED TO THE HOSPITAL HAD BEEN 731 MG/DL. CUSTOMER WAS TREATED WITH INSULIN AND WAS DIAGNOSED WITH DIABETES. CUSTOMER STATED HE REMAINED IN THE HOSPITAL FOR 2-2 1/2 DAYS. UPON DISCHARGE CUSTOMER WAS PRESCRIBED INSULIN AND HEART MEDICATIONS. PRIOR TO BEING HOSPITALIZED, CUSTOMER STATED THAT HE HAD BEEN PRE-DIABETIC AND HAD BEEN TAKING ORAL MEDICATION.

  Patient problems: Hyperglycemia

  MAUDE report 10693263 ↗
• MalfunctionOct 15, 2020Failure to Power Up; High Test Results; Failure to Power Up; High Test Results

  CONSUMER REPORTED COMPLAINT FOR METER NOT TURNING ON AND HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OBTAINED OF 234MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-170MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 234MG/DL FASTING USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 9/7/2020 AND OPEN VIAL DATE IS 10/15/2021. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10683924 ↗
• InjurySep 14, 2020Failure to Power Up; Failure to Power Up

  CONSUMER REPORTED COMPLAINT THAT THE TRUEMETRIX METER WAS NOT TURNING ON WHEN A TEST STRIP WAS INSERTED. CUSTOMER STATED SHE OBTAINED THE TRUEMETRIX METER FIVE MONTHS AGO AND THAT HE BATTERY HAS NEVER BEEN CHANGED. DURING THE CALL THE TRUEMETRIX METER DID NOT TURN ON BY USING THE POWER BUTTON OR WHEN A TEST STRIP WAS INSERTED. CUSTOMER STATED THAT SHE FELT TINGLING IN HER HEAD DUE TO HER DIABETES; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL.

  Patient problems: Tingling

  MAUDE report 10528131 ↗
• InjurySep 10, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-0 ERROR. CUSTOMER WAS RECENTLY DIAGNOSED WITH DIABETES. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED SYMPTOMS OF NAUSEA, HEADACHE AND DISORIENTATION. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER WAS NOT ABLE TO PROVIDE THE LOT NUMBER OF THE TEST STRIPS. INFORMATION WAS PROVIDED TO TECHNICIAN WHO ATTEMPTED TO CALL CUSTOMER AND WAS UNABLE TO REACH. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Confusion/ Disorientation; Headache; Nausea

  MAUDE report 10518682 ↗
• InjurySep 9, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH/HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH ALL TEST RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNKNOWN. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. CUSTOMER CONTACTED THE HOSPITAL ON (B)(6) 2020 DUE TO HIGH BLOOD RESULTS. CUSTOMER CONTACTED HER PRIMARY DOCTOR TODAY DUE TO HER BLOOD GLUCOSE RESULTS OF 391 MG/DL AND THE DOCTOR ADVISED HER TO TAKE ANOTHER PILL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. DURING THE CALL A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/31/2019 (EXPIRED) AND OPEN VIAL DATE IS AUGUST 2020. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. RESULT 1: HI, DATE: (B)(6) 2020, TIME: 8:08 PM, UNKNOWN IF FASTING OR NON-FASTING. RESULT 2: 600 MG/DL, DATE: (B)(6) 2020, TIME: 8:08 PM, UNKNOWN IF FASTING OR NON-FASTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10508196 ↗
• InjurySep 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER STATING THAT CUSTOMER HAD BEEN USING THE TRUEMETRIX METER AND THAT IT IS NO LONGER WORKING; HUSBAND WAS UNSURE OF THE EXACT ISSUE WITH THE TRUEMETRIX METER. HUSBAND STATED THAT CUSTOMER HAD BEEN IN THE HOSPITAL AND THEN REHAB FOR A FEW WEEKS AND AT RECENTLY RETURNED HOME. HUSBAND STATED THAT CUSTOMER HAS HEALTH ISSUES AND THAT THE MEDICAL ATTENTION COULD HAVE BEEN RELATED TO HER DIABETES. HUSBAND DECLINED TO PROVIDE ANY MORE DETAILS. CUSTOMER DID NOT HAVE ANY STRIPS AND HUSBAND STATED SHE WOULD BE GETTING FROM THE PHARMACY THE NEXT DAY AND THAT HE WOULD CALL BACK. HUSBAND DID NOT WANT TO PROVIDE A CONTACT TELEPHONE NUMBER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10479626 ↗
• MalfunctionSep 1, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 177, 190 AND 165 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70-130 MG/DL. 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, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 197 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/31/2021 AND OPEN VIAL DATE IS (B)(6) 2020. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10478563 ↗
• MalfunctionAug 17, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH ALL FIVE METER MEMORY TEST RESULTS. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 90 MG/DL AND NON-FASTING BLOOD GLUCOSE TEST RESULT 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, 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 CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10417432 ↗
• MalfunctionAug 11, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF HI; CUSTOMER WAS ALSO CONCERNED WITH METER MEMORY RESULTS OF 535, 522 AND 213 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, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 577 MG/DL AND 573 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 11/28/2021 AND OPEN VIAL DATE IS (B)(6) 2020. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10391352 ↗
• InjuryJul 24, 2020High Test Results; High Test Results

  CONSUMER HAD REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF HI. CUSTOMER STATED THAT HIS EXPECTED GLUCOSE TEST RANGE (DUE TO PREDNISONE) IS: 400-500 MG/DL NOON FASTING, 300-374 MG/DL AM FASTING. THE CUSTOMER REPORTED SYMPTOMS OF FREQUENT URINATION, EXCESSIVE THIRST, AND BEING VERY HUNGRY. CUSTOMER STATED THAT HE WAS GOING TO CALL HIS DOCTOR DUE TO THE HI AND HIS SYMPTOMS. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF HI USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/31/2021 AND OPEN VIAL DATE IS (B)(6) 2020. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 495 MG/DL, DATE: (B)(6) 2020, TIME: 4:39PM, NOON FASTING. RESULT 2: 374 MG/DL, DATE: (B)(6) 2020, TIME: 11:43AM, AM FASTING. RESULT 3: HI, DATE: (B)(6) 2020, TIME: 9:20PM, PM FASTING. RESULT 4: 374 MG/DL, DATE: (B)(6) 2020, TIME: 1:14AM, NOON FASTING. RESULT 5: HI, DATE: (B)(6) 2020, TIME: 9:13PM, PM FASTING.

  Patient problems: Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 10323087 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER CALLED FOR ASSISTANCE WITH PERFORMING CONTROL AND BLOOD GLUCOSE TESTS AS WELL AS SETTING THE TIME/DATE ON THE TRUEMETRIX METER. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULT OF 209 MG/DL USING TRUEMETRIX METER; CUSTOMER WAS COMFORTABLE WITH THE RESULT OBTAINED. THE CUSTOMER REPORTED FEELING NAUSEOUS, MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL.

  Patient problems: Nausea

  MAUDE report 10283838 ↗
• MalfunctionJun 12, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH CONTROL AND HIGH GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH CONTROL TESTS RESULTS FROM RESULTS OBTAINED OF 60MG/DL AND BLOOD TEST REULTS OF 128 AND 136MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-110MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IT IS STORED IN THE KITCHEN. DURING THE CALL A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/26/2021 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10150929 ↗
• MalfunctionJun 11, 2020High Test Results; Low Test Results; High Test Results; Low Test Results

  CONSUMER INITIALLY REPORTED COMPLAINT FOR E-2 ERROR MESSAGE. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 358 MG/DL USING TRUEMETRIX METER. CUSTOMER WAS CONCERNED THE RESULT OBTAINED WAS HIGH. THE CUSTOMER WAS ALSO CONCERNED WITH HIGH AND LOW TEST RESULTS FROM METER MEMORY OF 133, 87, 113, 230 AND 109 MG/DL. CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUE. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-160 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 STORED ACCORDING TO SPECIFICATION IN THE BEDROOM AND LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/31/2021 AND OPEN VIAL DATE IS (B)(6) 2020. (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10143150 ↗
• MalfunctionJun 9, 2020Measurement System Incompatibility; Measurement System Incompatibility

  CONSUMER REPORTED COMPLAINT FOR HIGH RESULTS ON ALLEGED RECALLED METER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OBTAINED OF 167MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURERS EXPIRATION DATE IS 10/28/2021 AND OPEN VIAL DATE IS ABOUT ONE WEEK AND A HALF AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6). SERIAL NUMBER REPORTED IS A RECALLED DEVICE DUE TO MEASUREMENT SYSTEM INCOMPATIBILITY - MMOL/L. HOWEVER, CUSTOMER STATED READING FROM METER IN MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10135636 ↗
• MalfunctionJun 1, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 155, 191, 157, 142 AND 274 MG/DL. THE CUSTOMERS EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 103-115 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, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 120 MG/DL AND 125 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURERS EXPIRATION DATE IS 09/30/2021 AND OPEN VIAL DATE IS MAY 2020. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10106224 ↗
• MalfunctionMay 12, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM PM FASTING RESULTS OBTAINED OF 193, 221, 169, 165 AND 174 MG/DL. THE CUSTOMER¿S EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-120 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, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 280 MG/DL AND 264 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/30/2021 AND OPEN VIAL DATE IS (B)(6) 2020. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10047268 ↗