TRUE METRIX TRUE METRIX Self Monitoring Blood Glucose Test StripsRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00021292012236), received between Oct 15, 2019 and Dec 5, 2025 — classified as 9 injuries, 14 malfunctions.

The most frequently reported specific device problem is “High Test Results” (12 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.

• MalfunctionDec 5, 2025Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. 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. PER CUSTOMER, THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (IN THE REFRIGERATOR). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/25/2026 AND PER THE CUSTOMER THE OPEN VIAL DATE WAS NOT PROVIDED. 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 (ONLY ONE RESULT PROVIDED): RESULT 1: LO. DATE: 11/6. TIME: UNKNOWN FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728289 ↗
• InjuryNov 7, 2021Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO AND LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO, 28 AND 84 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200-400 MG/DL. THE CUSTOMER HAD NOT BEEN USING THE PROPER TESTING TECHNIQUE (USING ALCOHOL PADS). THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT SHE HAD CALLED 911 ON (B)(6) 2021 DUE TO THE RESULTS OF LO AND 28 MG/DL. FIRE RESCUE HAD ARRIVED PRIOR TO THE PARAMEDICS AND HAD THE CUSTOMER EAT A BLUEBERRY MUFFIN WITH JUICE. THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN THE PARAMEDICS ARRIVED HAD BEEN 296 MG/DL NON-FASTING. A COMPARISON TEST WAS PERFORMED USING THE TRUE METRIX AIR METER AND THE RESULT HAD BEEN 84 MG/DL NON-FASTING. NO DIAGNOSIS WAS PROVIDED AND CUSTOMER WAS NOT TRANSPORTED TO THE HOSPITAL. CUSTOMER ALSO HAD GONE TO HER DOCTOR'S OFFICE THE SAME DAY AND HAD OBTAINED ANOTHER METER/TEST STRIPS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION; CUSTOMER STATED SHE HAD LEFT HER PURSE WITH HER TEST KIT IN A HOT CAR THE WEEK BEFORE. THE TEST S

  Patient problems: Hypoglycemia

  MAUDE report 12759735 ↗
• InjuryJun 14, 2021Failure to Power Up; Failure to Power Up

  CONSUMER REPORTED COMPLAINT FOR DEAD METER, STATING THAT THE TRUE METRIX AIR METER WOULD NOT POWER ON. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED THAT SHE WAS SWEATING; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. CUSTOMER STATED THAT THE BATTERY HAD BEEN CHANGED ON (B)(6) 2021; CUSTOMER IS USING THE CORRECT BATTERY FOR THE METER. THE BATTERY ORIENTATION HAD NOT BEEN CORRECT- THE BATTERY HAD BEEN TURNED INCORRECTLY IN THE METER. DURING THE CALL, THE METER POWERED ON USING THE POWER BUTTON AND WHEN A TEST STRIP WAS INSERTED. A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 169 MG/DL USING TRUE METRIX AIR METER; CUSTOMER WAS SATISFIED WITH THE RESULT OBTAINED.

  Patient problems: Diaphoresis

  MAUDE report 11990732 ↗
• InjuryMay 28, 2021Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-5). AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING VERY THIRSTY, MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. THE CUSTOMER WAS USING THE PROPER TESTING TECHNIQUES. DURING THE CALL, A 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 06/16/2022 AND TEST STRIPS WERE OPENED TWO WEEKS PRIOR TO CALL.

  Patient problems: Polydipsia

  MAUDE report 11900323 ↗
• MalfunctionMay 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT FOR HIGH CONTROL TEST RESULT. CUSTOMER ALSO REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH CONTROL TEST RESULT OF 176 MG/DL; BLOOD GLUCOSE TEST RESULTS OF CONCERN WERE NOT PROVIDED. CONTROL TEST RESULT IS NOT WITHIN THE ACCEPTABLE RANGE OF 94-126 MG/DL. CONTROL LEVEL TWO, LOT: #0BC2A43, MANUFACTURER¿S EXPIRATION DATE IS 02/28/2022 AND OPEN DATE IS (B)(6) 2021. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/31/2022 AND OPEN VIAL DATE WAS NOT DISCLOSED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. 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: Insufficient Information

  MAUDE report 11871618 ↗
• InjuryApr 1, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 176, 153 AND 139MG/DL. THE CUSTOMER DID NOT KNOW HIS EXPECTED GLUCOSE RANGE. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED HE HAD TESTED THREE DIFFERENT TIMES ON THE METER AND THE RESULTS HAD VARIED FROM 139 TO 153 TO 176MG/DL FASTING. CUSTOMER STATED HE DID NOT TRUST THE RESULTS AS HE WAS HAVING SYMPTOMS OF LOW BLOOD SUGAR (DIZZY AND LIGHTHEADED) AT THE TIME. CUSTOMER STATED HE WENT TO ER DUE TO THE SYMPTOMS. CUSTOMER STATED HIS BLOOD GLUCOSE TEST RESULT AT THE HOSPITAL OVER 30 MINUTES AFTER TESTING AT HOME HAD BEEN 122MG/DL FASTING. CUSTOMER STATED HE WAS NOT TREATED OR ADMITTED. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 211 MG/DL AND 241MG/DL USING TRUE METRIX METER; CUSTOMER WAS NOT SATISFIED WITH THE RESULTS OBTAINED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURERS EXPIRATION DATE IS 08/27/2021 AND OPEN VIAL DATE IS (B)(6) 2021. THE METER MEMORY WAS REVIEWED FO

  Patient problems: Dizziness

  MAUDE report 11605608 ↗
• InjuryMar 26, 2021Output Problem; Output Problem

  CONSUMER REPORTED COMPLAINT THAT THE TRUE METRIX AIR METER WOULD POWER UP BUT NOT GO INTO TEST MODE. AT THE TIME OF THE CALL THE CUSTOMER REPORTED HAVING BLURRY VISION; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/31/2022 AND OPEN VIAL DATE IS 02/26/2021. THE TRUE METRIX AIR METER DID NOT GO INTO TEST MODE DURING THE CALL AND THE CUSTOMER WAS UNABLE TO PERFORM A BLOOD TEST.

  Patient problems: Blurred Vision

  MAUDE report 11576298 ↗
• MalfunctionMar 24, 2021High 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 142, 131 AND 148 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 75-95 MG/DL. CUSTOMER STATED THAT THE TRUEMETRIXMETER WAS DROPPED AND SINCE THEN THE RESULTS HAVE BEEN HIGHER. 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 (KITCHEN). THE CUSTOMER DID HAVE ANOTHER VIAL OF TEST STRIPS. SAME LOT NUMBER, THAT HAD BEEN STORED AND HANDLED CORRECTLY. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 150 MG/DL AND 147 MG/DL USING TRUEMETRIX METER; CUSTOMER WAS SATISFIED WITH THE RESULTS OBTAINED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). HIGH BLOOD CUSTOMER CALLING CONCERN WITH THE RESULTS HE HAS BEEN GETTING FOR THE PAST FEW DAYS. CUSTOMER STATES THAT THE METER IS GIVING HIGH BLOOD RESULTS. CUSTOMER STATES THAT THEY INCREASE HIS INSULIN TO 24 UNITS FROM 22 UNITS 4DAYS AGO. CUSTOMER IS TAKING HIS I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11561982 ↗
• InjuryMar 22, 2021Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-3). THE CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUE (BLOOD SAMPLE ON TEST STRIP WHEN INSERTED INTO TRUEMETRIX METER). THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/21/2020 (EXPIRED) AND OPEN VIAL DATE IS 02/2021. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING USING THE EXPIRED TEST STRIPS AND PRODUCED TEST RESULT OF 246 MG/DL USING TRUEMETRIX METER; CUSTOMER WAS SATISFIED WITH THE RESULT OBTAINED. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING TIRED; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME.

  Patient problems: Fatigue

  MAUDE report 11542832 ↗
• MalfunctionJan 28, 2021High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-2). CUSTOMER JUST PURCHASED THE METER AND TEST STRIPS ON DAY OF CALL (B)(6) 2021. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULT OF HI USING THE METER. THE CUSTOMER WAS NOT CONCERNED WITH THE RESULT OBTAINED. 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 METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11244049 ↗
• MalfunctionDec 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 159 AND 398 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 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, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS BEING STORED IN THE KITCHEN. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. CUSTOMER WAS ALSO ADVISED THAT SHE HAS ANOTHER TEST STRIPS (RELION) NOT INTENDED FOR HER METER; CUSTOMER STATED ON THE BOX IT DOES STATE SHE CAN USE THESE STRIPS WITH TRUEMETRIX METER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11049791 ↗
• MalfunctionOct 28, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OBTAINED OF 185 AND 146MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120MG/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 DINING ROOM. DURING THE CALL A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER (WRONG STRIPS). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/30/2021 AND OPEN VIAL DATE IS ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10747811 ↗
• InjuryAug 17, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90MG/DL. THE CUSTOMER DID REPORT SYMPTOMS. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. CUSTOMER WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020. CUSTOMER STATED SHE WAS FEELING TIRED SO SHE DROVE HERSELF TO THE HOSPITAL ON (B)(6) 2020 DUE TO GETTING HIGHER THAN NORMAL RESULTS FROM HER METER. CUSTOMER WAS STILL IN THE HOSPITAL DURING INITIAL CALL AND IS EXPECTED TO BE DISCHARGED ON (B)(6) 2020. CUSTOMER WAS DIAGNOSED WITH HIGH BLOOD SUGAR. CUSTOMER WAS ADMITTED AND STATED THAT HER INSULIN WAS CHANGED. 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 MANUFACTURER¿S EXPIRATION DATE IS 11/20/2021 AND OPEN VIAL DATE IS 7/13/2020. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6).

  Patient problems: Hyperglycemia; Shaking/Tremors

  MAUDE report 10417623 ↗
• InjuryJul 9, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-0 ERROR. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING DIZZY AND HAVING BLURRY VISION. CUSTOMER STATED SHE WAS GOING TO SEEK MEDICAL INTERVENTION AND COULD NOT CONTINUE WITH THE CALL. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED. (B)(6).

  Patient problems: Blurred Vision; Dizziness

  MAUDE report 10250419 ↗
• InjuryMay 15, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-0 ACCOMPANIED BY SYMPTOMS. RESULTS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOM OF FREQUENT URINATION. CUSTOMER IS ANEMIC AND HAS CHRONIC PANCREATITIS (C-DIFF). MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS OR REPORTED SYMPTOM. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 158MG/DL FASTING USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 08/27/2021 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Anemia; Urinary Frequency / Polyuria

  MAUDE report 10063526 ↗
• MalfunctionMar 24, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF ABOVE 150MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-140MG/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 DINING AREA. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER (REFUSED). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 08/31/2020 AND OPEN VIAL DATE IS ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. TIME AND DATE ARE INCORRECT. (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9871604 ↗
• MalfunctionMar 16, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI AND HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER ALSO STATED RECEIVING MULTIPLE ERROR CODES WITH AND WITHOUT BLOOD SAMPLE. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF HI, 405, 434 AND 312 MG/DL; ALL RESULTS EXCEPT 312 MG/DL WERE NON-FASTING. THE CUSTOMER DID NOT KNOW HER EXPECTED GLUCOSE TEST RESULT RANGE. AT THE TIME OF THE CALL, THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED APPROXIMATELY 3 DAYS BEFORE CALLING, SHE HAD BEEN FEELING FATIGUE AND HAVING INCREASED URINATION. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 438 MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM/BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/16/2021 AND OPEN VIAL DATE IS 02/09/2020. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9836368 ↗
• MalfunctionFeb 12, 2020Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC AND HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 235, 110 AND 230 MG/DL AND BACK TO BACK BLOOD TESTS OF 300 AND 190 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 100 MG/DL. CUSTOMER WAS USING THE INCORRECT TEST STRIPS FOR THE TRUEMETRIX METER. CUSTOMER IS USING ALCOHOL PADS AND TEST FROM THE SAME FINGER/DIFFERENT HAND AT TIMES. 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 02/16/2021 AND TEST STRIPS WERE OPENED THREE WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9702125 ↗
• MalfunctionJan 14, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 241, 226, 243, 231 AND 316 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 - 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, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE CUSTOMER WAS NOT USING THE CORRECT TEST STRIPS FOR THE METER; CUSTOMER WAS USING TRUE METRIX RELION TEST STRIPS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/25/2021 AND OPEN VIAL DATE IS (B)(6) 2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 241MG/DL DATE: (B)(6) 2019 TIME: 01:07PM FASTING . RESULT 2: 226MG/DL DATE: (B)(6) 2019 TIME: 09:17AM FASTING. RESULT 3: 243MG/DL DATE: (B)(6) 2019 TIME: 06:23AM FASTING. RESULT 4: 231MG/DL DATE: (B)(6) 2019 TIME: 11:10AM FASTING. RESULT 5: 316MG/DL DATE: (B)(6) 2019 TIME: 10:30AM FASTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9587605 ↗
• MalfunctionDec 16, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 196 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 125 MG/DL. CUSTOMER STATED THAT HE ONLY TESTS IN THE MORNING FASTING, STATED HE HAS NEVER TESTED FASTING IN THE EVENINGS. 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 IT IS STORED IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/21/2021. 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 9472985 ↗
• MalfunctionNov 22, 2019High 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 389 MG/DL USING METER AND 304 MG/DL USING ANOTHER DEVICE. CUSTOMER STATED THAT HE WAS CONCERNED WITH THE HIGH RESULT OF 389 MG/DL SO HE HAD GONE TO THE CLINIC TO VERIFY HIS BLOOD GLUCOSE AND THE CLINIC HAD OBTAINED THE RESULT OF 304 MG/DL. CUSTOMER STATED THE CLINIC WAS RIGHT NEXT TO HIS WORK AND THE TESTS HAD BEEN PERFORMED ABOUT FIVE MINUTES APART, USING THE SAME HAND, DIFFERENT FINGER. CUSTOMER ALSO STATED HE DOES USE ALCOHOL PRIOR TO STICKING HIS FINGER TO TEST. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 250 - 270 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. DURING THE CALL, 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 09/21/2020 AND TEST STRIPS WERE OPENED ONE-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 9365325 ↗
• MalfunctionNov 18, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. CUSTOMER STATED SHE HAD OBTAINED THE HI RESULT THREE DAYS AGO. THE CUSTOMER IS ALSO CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 249 AND 340 MG/DL NON-FASTING AFTER TAKING MEDICATION. CUSTOMER STATED THAT SHE IS WAITING TWO HOURS AFTER A MEAL TO TEST, BUT IS TAKING HER MEDICATIONS 30 MINUTES TO ONE HOUR BEFORE PERFORMING A BLOOD TEST AT BEDTIME. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 140 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT ON 23-OCT-2019 SHE HAD GONE TO HER DOCTOR'S OFFICE DUE TO THE RESULT OF HI. CUSTOMER STATED THE DOCTOR TOLD HER THAT SHE WAS TOO LOW, SHE WAS DIAGNOSED WITH HYPOGLYCEMIA AND WAS GIVEN CANDY, PEANUTS AND RAISINS; CUSTOMER DID NOT DISCLOSE HER BLOOD GLUCOSE TEST RESULT WHEN AT THE DOCTOR'S OFFICE. CUSTOMER STATED HER DOCTOR DID TELL HER TO BEGIN TAKING 1/2 A TABLET OF HER GLIMEPIRIDE FOR A FEW DAYS AND SEE HOW HER GLUCOSE RESPONDS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 109 MG/DL AND 92 MG/DL USING METER. THE PRODUCT IS STORED ACCORDING TO

  Patient problems: Hypoglycemia

  MAUDE report 9336947 ↗
• MalfunctionOct 15, 2019Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OBTAINED OF 47 MG/DL AND 41 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 MG/DL - 138 MG/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 MANUFACTURER¿S EXPIRATION DATE IS 07/13/2019 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 9192202 ↗