TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 25 Test StripsRecalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00021292007829), received between Apr 6, 2017 and Apr 6, 2026 — classified as 1 death, 43 injuries, 49 malfunctions.

The most frequently reported specific device problem is “High Test Results” (49 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 93 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 208, 180, 221 AND 195 MG/DL. THE CUSTOMER DOES NOT KNOW HER EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER REPORTED FEELING ANXIOUS AND FELT IT MAY HAVE BEEN ASSOCIATED TO HER DIABETES; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. PER CUSTOMER, THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/26/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 1 WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER WAS UNABLE TO SEE TIME/DATE): RESULT 1: 208 MG/DL DATE: (B)(6) FASTING, RESULT 2: 180 MG/DL DATE: (B)(6) FASTING, RESULT 3: 221 MG/DL DATE: (B)(6) FASTING, RESULT 4: 195 MG/DL UNKNOWN.

  Patient problems: Anxiety

  MAUDE report 24788718 ↗
• InjuryFeb 9, 2026Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGES (E-2 AND E-3). SPOUSE IS CALLING ON BEHALF OF THE CUSTOMER. AT THE TIME OF THE CALL THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. PER CALLER, EMS HAD BEEN CALLED ON 01/08/2026 DUE TO CUSTOMER EXPERIENCING SYMPTOMS OF HIGH BLOOD GLUCOSE: CALLER STATED THE CUSTOMER HAD BEEN FEELING DIZZY AND HAD A WEIRD TASTE IN HIS MOUTH. CALLER STATED THAT THE CUSTOMER DID NOT HAVE THE TRUE METRIX METER WITH HIM; PER CALLER THE CUSTOMER HAD NOT BEEN TESTING FOR SOME TIME. CALLER STATED THE CUSTOMER HAD BEEN TAKEN TO THE ER AND WAS DIAGNOSED WITH HIGH BLOOD GLUCOSE AND GIVEN MEDICATION. THE CUSTOMER WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2026; CUSTOMER WAS GIVEN PRESCRIPTIONS, ADVISED TO START MONITORING HIS BLOOD SUGAR AND TO FOLLOW-UP WITH HIS PRIMARY CARE PHYSICIAN. PER CALLER, THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS BEING STORED IN THE CAR. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/31/2024 (EXPIRED). THE CUSTOMER DID HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY: LOT NUMBER ZD6004S, MANUFACTURER¿S EXPIRATION DATE IS 08/31/2026 AND OPEN VIAL DATE IS 01/14/2026. DURING THE

  Patient problems: Dizziness; Dysgeusia; Hyperglycemia

  MAUDE report 24297357 ↗
• InjuryOct 27, 2025Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER REPORTED FEELING TIRED; CUSTOMER STATED HE HAD BEEN IN THE ER THE NIGHT PRIOR. CUSTOMER STATED HIS DOCTOR CALLED HIM YESTERDAY TO GIVE HIM THE RESULT OF HIS LAB BLOOD WORK. DOCTOR HAD ADVISED HIM TO GO TO THE ER AS HIS BLOOD RESULTS SHOWED HIS GLUCOSE WAS OVER 700 MG/DL. CUSTOMER WENT TO THE ER AND THEY RAN HIS BLOOD SUGAR AND THEIR METER SHOWED IT WAS IN THE 400'S. CUSTOMER HAD TAKEN THE TRUE METRIX AIR METER TO ER AND IT SHOWED RESULTS IN THE 180'S. THE DIAGNOSIS WAS HIGH BLOOD GLUCOSE AND CUSTOMER WAS TREATED WITH INSULIN TO LOWER HIS BLOOD GLUCOSE LEVEL. CUSTOMER STATED DUE TO LOW BLOOD GLUCOSE RESULTS HE HAD ALSO GONE TO THE ER ON (B)(6) 2025; NO FURTHER DETAILS WERE PROVIDED. CUSTOMER STATED HE HAS BEEN IN AND OUT OF THE HOSPITAL PREVIOUSLY REGARDING HIS BLOOD SUGAR. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE AND RESULTS OF CONCERN WERE NOT PROVIDED. THE CUSTOMER'S TEST STRIPS WERE EXPIRED AT THE TIME OF THE CALL: MANUFACTURER'S EXPIRATION DATE IS 09/27/2025; PRODUCT STORAGE AND OPEN VIAL DATE WERE NOT PROVIDED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Fatigue; Hyperglycemia

  MAUDE report 23393265 ↗
• DeathSep 19, 2025Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-5). SISTER IS CALLING ON BEHALF OF THE CUSTOMER. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED E-5 ERROR MESSAGE USING TRUE METRIX METER. CUSTOMER WAS EXPERIENCING HALLUCINATIONS AND CONFUSION. CALLER ASKED IF SHE SHOULD GIVE CUSTOMER INSULIN AND WAS ADVISED THAT MANUFACTURER IS UNABLE TO ADVISE AS TO MEDICATION. CALLER THEN STATED THAT SHE IS GOING TO CALL THE PARAMEDICS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/29/2027 AND OPEN VIAL DATE IS 08/26/2025.

  Patient problems: Confusion/ Disorientation; Dyspnea; Hallucination; Hyperglycemia

  MAUDE report 23099374 ↗
• MalfunctionApr 23, 2025High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED FROM AM FASTING METER TO METER COMPARISON OF 100 MG/DL USING TRUE METRIX GO METER AND 30 MG/DL USING ANOTHER DEVICE. 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 TEST STRIPS ARE EXPIRED: MANUFACTURER¿S EXPIRATION DATE IS 09/28/2024; OPEN VIAL DATE AND PRODUCT STORAGE WAS NOT PROVIDED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892494 ↗
• MalfunctionApr 22, 2025High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 224, 212, 164 AND 275 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 97-140 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 STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/29/2026 AND OPEN VIAL DATE IS A WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 224 MG/DL , DATE : (B)(6), TIME: 10:21AM FASTING, RESULT 2: 212 MG/DL, DATE: (B)(6), TIME: 8:32AM FASTING , RESULT 3: 164 MG/DL, DATE: (B)(6), TIME: 11:00AM FASTING , RESULT 4: 123 MG/DL, DATE: (B)(6), TIME: 12:00PM FASTING , RESULT 5: 275 MG/DL, DATE: (B)(6), TIME: 7:30AM FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882975 ↗
• MalfunctionMar 24, 2025High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. PHARMACY IS CALLING ON BEHALF OF THE CUSTOMER; PHARMACY IS CALLING FOR A COUPON TO REPLACE THE CUSTOMER'S METER. RESULTS OF CONCERN AND THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS NOT PROVIDED. 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 TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 7/30/2025; PRODUCT STORAGE AND OPEN VIAL DATE WERE NOT PROVIDED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. COORDINATOR HAD INITIALLY SPOKEN WITH CUSTOMER AND TRANSFERRED CUSTOMER'S INFORMATION TO TECHNICIAN. TECHNICIAN WAS UNABLE TO CONTACT THE CUSTOMER VIA TELEPHONE, NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679732 ↗
• InjuryMar 21, 2025Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-2). THE CUSTOMER REPORTED NOT FEELING WELL; CUSTOMER STATED THAT HE IS HAVING PAIN INSIDE (EXACT SYMPTOMS NOT PROVIDED) AND CUSTOMER BELIEVED HIS BLOOD GLUCOSE WAS HIGH. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 402 MG/DL USING TRUE METRIX GO METER. CUSTOMER IS AWARE THAT HIS BLOOD GLUCOSE IS HIGH BECAUSE HIS DR. RECENTLY INCREASED HIS METFORMIN (CUSTOMER DID NOT ADVISE IF THIS WAS DURING A SCHEDULED APPOINTMENT). THE PRODUCT IS STORED ACCORDING TO SPECIFICATION; CUSTOMER STATED HE HAD THE STRIPS IN HIS TRUCK BUT JUST OPENED THEM LAST NIGHT. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/30/2025.

  Patient problems: Pain

  MAUDE report 21665796 ↗
• InjuryFeb 7, 2025Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-2). THE CUSTOMER REPORTED FEELING DIZZY; CUSTOMER STATED THAT SHE HAD CONTACTED THE DOCTOR ON THE DAY OF THE CALL BUT HAD NOT BEEN ABLE TO SPEAK WITH THE DOCTOR. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED E-2 ERROR MESSAGE USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/19/2026 AND OPEN VIAL DATE IS (B)(6) 2025.

  Patient problems: Dizziness

  MAUDE report 21334679 ↗
• InjuryNov 15, 2024High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS AND ERROR MESSAGES (E-3 AND E-5). THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED ON (B)(6) 2024 OF 445 AND 475 MG/DL (FASTING/NON-FASTING WAS NOT DISCLOSED). THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS NOT PROVIDED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT DUE TO THE HIGH RESULTS AND ERROR MESSAGES SHE HAD CONTACTED HER DOCTOR ON THE DAY OF THE CALL. CUSTOMER STATED THAT THE DOCTOR WAS OUT OF THE OFFICE, AND SHE WAS NOT GIVEN ANY INSTRUCTIONS. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/19/2026 AND OPEN VIAL DATE WAS NOT PROVIDED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Hyperglycemia

  MAUDE report 20698015 ↗
• InjuryJul 23, 2024High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM METER TO METER COMPARISON OF 140 MG/DL FASTING USING TRUE METRIX METER AND 50 MG/DL FASTING USING ANOTHER DEVICE. THE CUSTOMER DOES NOT KNOW HER EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT YESTERDAY SHE HAD TAKEN HER INSULIN AFTER OBTAINING A RESULT OF 412 MG/DL FASTING. CUSTOMER STATED SHE TESTED AGAIN AT 11:29AM AND OBTAINED 253 MG/DL FASTING AND AGAIN AT 12:18PM AND OBTAINED 140 MG/DL FASTING, CUSTOMER STATED SHE HAD NOT BEEN FEELING WELL, SHE HAD BEEN FEELING SHAKY. CUSTOMER STATED SHE CALLED METRO HEALTH AND SPOKE TO A NURSE PRACTITIONER WHO ADVISED HER TO CALL 911 AND TAKE HER INSULIN. WHEN PARAMEDICS CAME ABOUT < 10 MINUTES LATER AND TESTED HER BLOOD GLUCOSE IT WAS 50MG/DL STILL FASTING; CUSTOMER DID NOT DISCLOSE IF SHE HAD TAKEN THE INSULIN AS ADVISED. CUSTOMER WAS TAKEN TO THE HOSPITAL. CUSTOMER DID NOT RECALL HER BLOOD GLUCOSE TEST RESULT WHEN AT THE HOSPITAL. THE DIAGNOSIS WAS LOW BLOOD SUGAR. NO MEDICAL TREATMENT WAS GIVEN OTHER THAN A SANDWICH AT THE HOSPITAL. CUSTOMER WAS THEN DISC

  Patient problems: Hypoglycemia; Shaking/Tremors

  MAUDE report 19812238 ↗
• MalfunctionMay 13, 2024High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI; CUSTOMER STATED THAT SHE TESTED TWICE AND OBTAINED HI. THE CUSTOMER DOES NOT KNOW HER EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. CUSTOMER STATED THAT SHE TOOK HER BLOOD GLUCOSE WITH HER CBGM AND IT READ A LITTLE OVER 200 MG/DL NON-FASTING (CUSTOMER STATED THAT HER CBGM EXPIRED SO SHE HAD TO REMOVE IT). 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 NON-FASTING AND PRODUCED TEST RESULT OF HI USING TRUE METRIX METER. THE PRODUCT IS (NOT) STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/30/2025 AND OPEN VIAL DATE IS (B)(6) 2024. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298143 ↗
• InjuryApr 11, 2024Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-0). DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED E-0 AND E-5 ERROR MESSAGES USING TRUE METRIX GO METER. THE CUSTOMER STATED SHE HAD INCREASED THIRST AND WAS DRINKING A LOT; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/31/2024 AND TEST STRIPS WERE OPENED 2 WEEKS PRIOR TO THE CALL.

  Patient problems: Polydipsia

  MAUDE report 19088333 ↗
• InjuryMar 18, 2024Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-3). THE CUSTOMER REPORTED FEELING NAUSEATED; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 133 MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION; THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/30/2025 AND OPEN VIAL DATE IS 02/21/2024.

  Patient problems: Nausea

  MAUDE report 18924390 ↗
• MalfunctionDec 11, 2023High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI. HUSBAND STATED THAT CUSTOMER HAD BEEN DIZZY AND THIRSTY ON 11/15/2023. HUSBAND STATED THAT LATER AFTER DINNER THE CUSTOMER HAD FELT BETTER. HUSBAND STATED CUSTOMER DID NOT PERFORM ANOTHER BLOOD TEST PRIOR TO GOING TO BED. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS NOT DISCLOSED. 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 AND REPORTED SYMPTOMS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/28/2024; PRODUCT STORAGE AND OPEN VIAL DATE WERE NOT DISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Dizziness; Polydipsia; Unspecified Infection

  MAUDE report 18300242 ↗
• MalfunctionNov 29, 2023High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULT OBTAINED OF 861 MG/DL; CUSTOMER COULD NOT RECALL THE DATE HE OBTAINED THE RESULT AND RESULT COULD NOT BE CONFIRMED IN METER MEMORY. THE CUSTOMER DOES NOT KNOW HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT DUE TO THE HIGH RESULTS HE HAD CONTACTED THE NURSE ON (B)(3) 2023 AND WENT TO SEE THE DOCTOR THE FOLLOWING DAY. CUSTOMER DID NOT RECEIVE ANY MEDICAL TREATMENT AND CUSTOMER WAS ADVISED TO REPLACE METER. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/31/2024; STORAGE AND OPEN VIAL DATE WERE NOT DISCLOSED. AFTER REVIEWING THE RESULTS WITH CUSTOMER, CUSTOMER WAS NOT CONCERNED WITH ANY OF THE RESULTS IN THE METER AND AGREED THE RESULT HE THOUGHT HE SAW DID NOT EXIST IN THE METER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 110 MG/DL, DATE: (B)(3) 2023, TIME: 6:32AM, FASTING; RESULT 2: 114 MG/DL, DATE: (B)(3) 2023, TIME: 6:18AM, FASTING; RESULT 3: 82 MG/DL, DATE: (B)(3) 2023,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18231111 ↗
• InjuryOct 18, 2023Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGES (E-2, E-3 AND E-1). THE CUSTOMER REPORTED HAVING A HEADACHE; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (STORED IN CUSTOMER'S CAR). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/28/2025 AND OPEN VIAL DATE WAS NOT DISCLOSED. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY.

  Patient problems: Headache

  MAUDE report 17956273 ↗
• MalfunctionOct 5, 2023Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 136, 108 AND 82 MG/DL. CUSTOMER STATED THE RESULTS WERE LOWER THAN HIS PREVIOUS METER. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT IS 150 MG/DL OR HIGHER; CUSTOMER STATED THAT IT WAS THE SAME AM FASTING AND PM NON-FASTING. 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 STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/24/2025 AND OPEN VIAL DATE IS LESS THAN ONE MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 : 136 MG/DL DATE: 9/12/23 TIME: 1:00PM NON-FASTING PM RESULT 2 : 108 MG/DL DATE: 9/12/23 TIME: 6:02AM FASTING AM RESULT 3 : 162 MG/DL DATE: 9/11/23 TIME: 11:06PM NON-FASTING PM RESULT 4 : 82 MG/DL DATE: 9/11/23 TIME: 8:11PM NON-FASTING PM RESULT 5 :150 MG/DL DATE: 9/11/23 TIME: 11:14AM NON-FASTING AM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17882148 ↗
• MalfunctionSep 29, 2023High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI AND HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI AND 536 MG/DL. THE CUSTOMER DOES NOT KNOW HER EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER REPORTED HAVING BLURRY VISION; CUSTOMER STATED SHE HAS BEEN HAVING IT FOR THE PAST COUPLE OF DAYS. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/30/2024 AND OPEN VIAL DATE WAS NOT DISCLOSED. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE (KITCHEN). THE CUSTOMER DID HAVE ANOTHER VIAL OF TEST STRIPS, SAME LOT NUMBER, OPENED DAY OF CALL, THAT HAD BEEN STORED AND HANDLED CORRECTLY. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF HI USING TRUE METRIX AIR METER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER WAS UNABLE TO SEE DATE): RESULT 1: HI TIME: 10:20 AM NON-FASTING. RESULT 2: HI TIME: 6:23 PM FASTING. RESULT 3: HI TIME: 5:28 PM UNKNOWN. RESULT 4: HI TIME 1:08 PM FASTING. RESULT 5: 536 MG/DL TIME: 10:40 PM FASTING.

  Patient problems: Blurred Vision

  MAUDE report 17843064 ↗
• InjuryAug 24, 2023Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-3). THE CUSTOMER REPORTED SYMPTOM OF LOW ENERGY; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (BATHROOM). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/30/2024 AND OPEN VIAL DATE WAS NOT DISCLOSED. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY.

  Patient problems: Lethargy

  MAUDE report 17616446 ↗
• InjuryJun 19, 2023Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-3). THE CUSTOMER REPORTED FEELING SHAKY AND NAUSEOUS; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 116 MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/28/2024 AND TEST STRIPS WERE OPENED A FEW DAYS PRIOR TO THE CALL.

  Patient problems: Nausea; Shaking/Tremors

  MAUDE report 17154166 ↗
• MalfunctionJun 14, 2023High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM METER TO METER COMPARISON OF 158 MG/DL USING TRUE METRIX METER AND 60 MG/DL USING ANOTHER DEVICE. CUSTOMER REPORTED THE COMPARISON TESTS HAD BEEN PERFORMED AM FASTING THE DAY PRIOR AND THAT THEY HAD BEEN SWEATING AT THE TIME. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS < 126 MG/DL. 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 AND REPORTED SYMPTOM(S). DURING THE CALL, METER TO METER COMPARISON BLOOD TESTS WERE PERFORMED BY THE CUSTOMER PM FASTING AND PRODUCED TEST RESULTS OF 214 MG/DL USING TRUE METRIX METER AND 108 MG/DL USING ANOTHER DEVICE. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/28/2024 AND OPEN VIAL DATE IS 05/17/2023. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Diaphoresis

  MAUDE report 17126021 ↗
• MalfunctionApr 17, 2023High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 161, 244 AND 226 MG/DL. ERRATIC (BACK TO BACK) BLOOD GLUCOSE TEST RESULTS WERE NOT PROVIDED. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150-160 MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-130 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 STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/19/2023 AND TEST STRIPS WERE OPENED A FEW WEEKS PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE NOT SET): RESULT 1: 185 MG/DL , DATE:(B)(6), TIME: 11:46 AM FASTING. RESULT 2: 112MG/DL , DATE: (B)(6),TIME: 4:19 PM FASTING. RESULT 3: 161MG/DL , DATE: (B)(6), TIME: 9:56 AM FASTING. RESULT 4: 244 MG/DL, DATE: (B)(6), TIME: 10:08 AM FASTING. RESULT 5: 226 MG/DL , DATE: (B)(6), TIME: 9:07 PM FASTING. RESULT 6: 88 MG/DL , DATE: (B)(

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16754527 ↗
• InjuryApr 11, 2023High Test Results; High Test Results

  CONSUMER HAD INITIALLY REPORTED COMPLAINT FOR E-5 ERROR. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER WAS USING TEST STRIP LOT ZY4480S, WHICH WAS NOT BEING STORED ACCORDING TO SPECIFICATION (BATHROOM). THE CUSTOMER DID HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY: LOT ZA4878S, MANUFACTURER¿S EXPIRATION DATE IS 02/29/2024 AND OPENED DAY OF CALL. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AM FASTING AND PRODUCED TEST RESULT OF HI USING TRUE METRIX METER AND TEST STRIP LOT ZA4878S. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS NOT DISCLOSED. THE CUSTOMER REPORTED FEELING TIRED; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Fatigue; Hyperglycemia

  MAUDE report 16713960 ↗
• InjuryFeb 28, 2023Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 60, 41, 50, 112 AND 44 MG/DL AND FROM METER TO METER COMPARISON OF 112 MG/DL USING TRUE METRIX AIR METER AND 140 MG/DL USING ANOTHER DEVICE. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. ON (B)(6) 2023, CUSTOMER HAD BEEN FEELING LETHARGIC AND HAD SLURRED SPEECH. CUSTOMER HAD TESTED USING THE TRUE METRIX AIR METER AND HAD OBTAINED A RESULT OF 43 MG/DL. 911 HAD BEEN CALLED; EMT'S HAD DIAGNOSED CUSTOMER WITH LOW BLOOD SUGAR AND GIVEN CUSTOMER GLUCOSE GEL. CUSTOMER'S BLOOD GLUCOSE TEST RESULT USING THEIR DEVICE HAD BEEN 140 MG/DL; BLOOD TEST WAS THEN PERFORMED USING THE TRUE METRIX AIR METER AND THE RESULT OBTAINED HAD BEEN 112 MG/DL. CUSTOMER'S FAMILY HAD DECLINED HER GOING TO THE HOSPITAL. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER; CUSTOMER WAS AT HER INFUSION APPOINTMENT AND COULD NOT TEST. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTUR

  Patient problems: Hypoglycemia; Lethargy; Speech Disorder

  MAUDE report 16451853 ↗