TRUE METRIX AIR TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE METER (REF REA4H01-43)Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00021292007911), received between Nov 29, 2016 and Jan 15, 2019 — classified as 56 malfunctions.

The most frequently reported specific device problem is “High Test Results” (31 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2019High Test Results; Adverse Event Without Identified Device or Use Problem; High Test Results; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. CUSTOMER IS CONCERNED WITH TESTS RESULTS OF HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 125 MG/DL. AT THE TIME OF THE CALL,THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT ON (B)(6) 2018, SHE WAS SHAKING AND HAVING INCREASED URINATION SO SHE WENT TO THE DOCTOR. CUSTOMER STATED THAT SHE WAS AT HER DOCTOR'S OFFICE AND WAS ADVISED TO GO STRAIGHT TO THE HOSPITAL. CUSTOMER WAS ADMITTED ON (B)(6) 2018. CUSTOMER STATED THAT WHEN SHE FIRST GOT TO THE HOSPITAL, THEY WERE UNABLE TO TEST HER BLOOD SUGAR, BUT WHEN THEY EVENTUALLY GOT A RESULT IT WAS 900 MG/DL FASTING. CUSTOMER STATED THAT SHE WAS GIVEN AN INSULIN DRIP TO LOWER HER BLOOD GLUCOSE. CUSTOMER WAS DISCHARGED ON (B)(6) 2018, AND WAS ADVISED BY THE DISCHARGING PHYSICIAN TO FOLLOW-UP WITH HER PRIMARY CARE DOCTOR. CUSTOMER DID DISCLOSE THAT SHE HAD STOPPED TAKING HER METFORMIN MEDICATION AT LEAST 4-5 DAYS PRIOR TO GOING TO HER DOCTOR. DURING THE CALL ON (B)(6) 2018, A BACK-TO-BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF HI AND HI USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORD

  Patient problems: Shaking/Tremors; Urinary Frequency / Polyuria

  MAUDE report 8249711 ↗
• MalfunctionJan 11, 2019Low Test Results; Low Test Results

  CONSUMER INITIALLY REPORTED COMPLAINT FOR E-3 ERROR: USED TEST STRIP, TEST STRIP OUTSIDE OF VIAL TOO LONG, SAMPLE ON TOP OF TEST STRIP. THE CUSTOMER'S TEST STRIPS WERE EXPIRED: LOT # MT2239, MANUFACTURER'S EXPIRATION DATE OF 05/22/2018. CUSTOMER DID NOT HAVE ANOTHER VIAL AND WAS GOING TO PURCHASE. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING SLIGHTLY TIRED AND STATED IT WAS DUE TO HER BLOOD SUGAR. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL ON (B)(6) 2018. CUSTOMER REPORTED A PAST ADVERSE EVENT STATING SHE HAD TAKEN A MEDICATION THAT SEEMED TO HAVE LOWERED HER BLOOD GLUCOSE AND THAT SHE DOES NOT REMEMBER WHAT HAPPENED AND WAS TAKEN TO THE HOSPITAL. SPOKE WITH CUSTOMER'S GRANDDAUGHTER TO OBTAIN FURTHER DETAILS. ON (B)(6) 2018, CUSTOMER WAS UNCONSCIOUS AND UNRESPONSIVE, HAD BEEN SNORING VERY LOUDLY AND DROOLING. 911 HAD BEEN CALLED. THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT WITH THE PARAMEDIC'S METER WAS 46 MG/DL FASTING. THE CUSTOMER WAS TAKEN TO THE HOSPITAL; THE DIAGNOSIS WAS HYPOGLYCEMIA. THE CUSTOMER AND GRANDDAUGHTER DID NOT KNOW WHAT TREATMENT WAS RECEIVED. THE CUSTOMER WAS DISCHARGED AT 5:00 AM ON (B)(6) 2018. NO NEW MEDICATIONS OR HEALTHCARE PROGRAM HAD

  Patient problems: Fatigue

  MAUDE report 8241957 ↗
• MalfunctionJan 2, 2019Unable 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 ERROR CODE. THE E-5 ERROR OCCURRED AS SOON AS THE BLOOD SAMPLE WAS ABSORBED. SON IS CALLING ON BEHALF OF THE CUSTOMER. AT THE TIME OF THE CALL ON (B)(6) 2018, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. SON STATED THAT ON (B)(6) 2018, THE CUSTOMER HAD OBTAINED THE E-5 ERROR ON THREE DIFFERENT METERS; CUSTOMER WAS FASTING AT TIME. INFORMATION WAS ONLY ABLE TO BE OBTAINED FOR THE TRUEMETRIX AIR METER. SON STATED THAT HE HAD CALLED 911; THE PARAMEDICS HAD ARRIVED AND CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN TESTED USING THEIR METER WAS 556MG/DL FASTING. SON HAD TAKEN CUSTOMER TO HOSPITAL WHERE SHE WAS DIAGNOSED WITH HIGH BLOOD SUGAR AND A STOMACH INFECTION. CUSTOMER WAS GIVEN INSULIN AND ANTIBIOTICS. CUSTOMER WAS RELEASED ON (B)(6) 2018. CUSTOMER DISCONNECTED THE CALL AND NO FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

  Patient problems: Hyperglycemia

  MAUDE report 8209805 ↗
• MalfunctionDec 26, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 145 MG/DL. CUSTOMER STATED THAT SHE HAD A MEAL LAST EVENING THAT SHE SHOULD NOT HAVE EATEN. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED SYMPTOMS OF INCREASED THIRST AND FREQUENT URINATION BUT DENIED THE NEED FOR MEDICAL ATTENTION AT THE TIME. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF HI AND HI USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2019 AND OPEN VIAL DATE IS A FEW WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER IS CONCERNED WITH THE HI RESULTS THAT SHE IS GETTING FROM HER METER. CUSTOMER HAS NOT HAD ANY CHANGES TO HER MEDICATION, LIFESTYLE, MEDICATION OR DIET ROUTINE. CUSTOMER STATES THAT SHE DOES TRY TO EXERCISE A LITTLE EVERY DAY. CUSTOMER ALSO STATED THAT SHE HAD A MEAL LAST EVENING THAT SHE SHOULD NOT HAVE EATEN. CUSTOMER IS CURRENTLY HAVING INCREASED THIRST AND FREQ

  Patient problems: Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 8196328 ↗
• MalfunctionDec 13, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER IS CONCERNED WITH ALL TESTS RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70-90MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS. 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 IN THE BATHROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2019 AND OPEN VIAL DATE IS FOUR DAYS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED IN STATING THAT THE METER IS READING LOWER THAN IT SHOULD. CUSTOMER STATES THAT WHEN SHE TESTS NON-FASTING HER RESULTS ARE TOO LOW. SHE STATES THAT SHE HAS GESTATIONAL PRE-DIABETES. THE DOCTOR INSTRUCTED HER TO TEST ONE HOUR AFTER MEAL. SHE STATES THAT HER NON-FASTING RESULTS ARE TAKING ONE HOUR AFTER SHE EATS THINGS LIKE, PIZZA AND ICE CREAM. SHE BELIEVES THAT THE RESULTS SHOULD BE HIGHER THAN 130 MG/DL. EDUCATED CUSTOMER REGARDING STORAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8160179 ↗
• MalfunctionNov 28, 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 294 AND 257 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 200 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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/18/2020 AND TEST STRIPS WERE OPENED LAST WEEK. CUSTOMER WAS NOT USING PROPER TESTING TECHNIQUE WHEN BACK TO BACK TESTS IN THE METER MEMORY WERE PERFORMED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8113295 ↗
• MalfunctionOct 12, 2018High Test Results; High Test Results

  CONSUMER INITIALLY REPORTED COMPLAINT FOR E-5 ERROR: TEST STRIP ERROR. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING ILL WITH SYMPTOMS OF BLURRY VISION AND FATIGUE. CUSTOMER WAS GOING TO SEEK MEDICAL ATTENTION AND WAS NOT ABLE TO CONTINUE WITH THE TROUBLESHOOTING PROCESS. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Blurred Vision; Fatigue

  MAUDE report 7960363 ↗
• MalfunctionOct 3, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO AND LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF LO, 65 AND 32 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 120 MG/DL. CUSTOMER ALSO STATED THE TRUEMETRIX AIR METER WAS GIVING ERROR MESSAGES. 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 10/17/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :121MG/DL DATE: (B)(6) 2018 TIME:6:53 PM FASTING; RESULT 2 :65MG/DL DATE: (B)(6) 2018 TIME:10:05PM FASTING; RESULT 3 : LO DATE: (B)(6) 2018 TIME:7:20PM FASTING; RESULT 4 : 32MG/DL DATE: (B)(6) 2018 TIME:7:16PM FASTING; RESULT 5 : 140MG/DL DATE: (B)(6) 2018 TIME:7:07AMFASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7930620 ↗
• MalfunctionSep 28, 2018High Test Results; High Test Results

  CUSTOMER CALLING CONCERN WITH THE HIGHER RESULTS THE METER IS GIVING. CUSTOMER STATES THAT SHE GOT A FALSE READING AND THEN ENDED UP IN THE ER. ON (B)(6) 2018 CUSTOMER GOT UP AND TOOK HER INSULIN THEN WENT TO THE DOCTOR'S OFFICE AT 930AM BECAUSE OF A PREVIOUS APPOINTMENT TO CHECK ON HER LEG THAT WAS AMPUTATED. CUSTOMER DID NOT EAT ANYTHING. CUSTOMER STATES THAT SHE EXPLAINS TO THE NURSE THAT SHE WAS NOT FEELING WELL, CUSTOMER STATES THAT SHE WAS SHAKING AND FEELING HOT. THEY RUN A BLOOD TEST AND GOT A RESULT OF 60MG/DL FASTING. CUSTOMER STATES THAT THEY GAVE HER SOME CRANBERRY JUICE AND SHE PASS OUT AND THEY CALL 911 AND SHE WENT TO THE HOSPITAL. THE RESULT AT THE HOSPITAL WAS 62MG/DL NON-FASTING. THE HOSPITAL GAVE HER SUGAR WATER AND IV TO GET HER BLOOD SUGAR BACK UP. CUSTOMER STAY AT THE HOSPITAL AND WAS RELEASE ON (B)(6) 2018. CUSTOMER NORMAL GLUCOSE RANGE IS 200-230MG/DL FASTING, AND SHE TESTS HER BLOOD SUGAR 5 TIMES A DAY. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/24/2019 AND OPEN VIAL DATE IS ONE WEEK AGO. THE M

  Patient problems: Fainting; Hypoglycemia; Shaking/Tremors

  MAUDE report 7920656 ↗
• MalfunctionAug 16, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 127 AND 82 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 -250 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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE BATHROOM AND IN CUSTOMER'S PURSE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/29/2019 AND OPEN VIAL DATE IS TWO MONTHS. CUSTOMER HAD DISCONNECTED CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 127MG/DL, DATE: (B)(6) 2018, TIME: 7:50AM, FASTING. RESULT 2: 82MG/DL, DATE: (B)(6) 2018, TIME: 7:27PM, FASTING. CUSTOMER DISCONNECTED CALL WITH CCR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7790741 ↗
• MalfunctionJul 5, 2018High 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 135 TO 160MG/DL. THE CUSTOMER DID REPORT SYMPTOM OF A HEADACHE. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:393MG/DL DATE:(B)(6) 2018 TIME:9:23AM FASTING, RESULT 2:369MG/DL DATE: (B)(6) 2018 TIME:12:48AM FASTING, RESULT 3:372MG/DL DATE (B)(6) 2018 TIME:12:47AM FASTING, RESULT 4:405MG/DL DATE:(B)(6) 2018 TIME:12:05AM FASTING, RESULT 5:420MG/DL DATE (B)(6) 2018 TIME:10:37PM FASTING.

  Patient problems: Headache

  MAUDE report 7664748 ↗
• MalfunctionJul 3, 2018Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR METER DISPLAY OF PARTIAL DASHES ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOM OF INCREASED THIRST. 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 ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TWO DASHES USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/29/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. METER DISPLAYS TWO ROWS OF DASHES ON THE SCREEN A SOON AS METER IS TURNED ON DISPLAYS 2 DASHED LINES APPEAR.

  Patient problems: Polydipsia

  MAUDE report 7658777 ↗
• MalfunctionJun 25, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR E-5 AND HIGH BLOOD GLUCOSE RESULTS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. 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)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF E-5 USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/25/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER WAS TOLD THAT HIS BLOOD GLUCOSE WAS OVER 900MG/DL FROM THE LAB RESULTS DONE AT THE HOSPITAL (PART OF ROUTINE CHECKUP). HE THEN TRIED TO RUN HIS BLOOD AND GOT AN E-5 AFTER BLOOD IS ABSORBED INTO THE STRIPS. I EXPLAINED WHAT THAT MEANT AND ASKED IF THE DOCTOR OR HOSPITAL GAVE INSTRUCTIONS ON WHAT TO DO. CUSTOMER RESPONDED- NO! I ADVISED HER TO CALL THE DR OR 911 FOR SOME ADVICE AND TO RECHECK HIS BLOOD SUGAR -IF DOCTOR IS NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7634092 ↗
• MalfunctionJun 21, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. INSURANCE NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNKNOWN. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING DIZZY AND HAD CHEST PAIN. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/23/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). CALLED CUSTOMER BACK AFTER HIS INSURANCE AGENT CALLED IN TO REPORT THAT HE SOUGHT MEDICAL INTERVENTION WHILE USING OUR METER. CUSTOMER STATES THAT ON (B)(6) 2018, HE WAS FEELING DIZZY AND HAD CHEST PAIN. CUSTOMER STATES THAT HE CHECKED HIS BLOOD SUGAR WITH OUR METER AND THE RESULTS WAS 308 MG/DL NON-FASTING, CUSTOMER CALLED THE PARAMEDIC AND THEY ARRIVED WITHIN 10-MINUTES, THEY CHECKED HIS BLOOD SUGAR WITH THEIR METER AND THE RE

  Patient problems: Chest Pain; Dizziness; Hyperglycemia

  MAUDE report 7625398 ↗
• MalfunctionMay 22, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM METER TO METER COMPARISON OF 164 MG/DL USING TRUEMETRIX AIR METER AND 126 MG/DL USING ANOTHER DEVICE, AND FROM RESULTS OBTAINED OF 246 AND 275 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140 - 160 MG/DL. CUSTOMER ALSO STATED THAT AT A ROUTINE DOCTOR'S APPOINTMENT, THE TRUEMETRIX AIR METER READ HIGHER THAN THE DOCTOR'S METER; ACTUAL METER TO METER COMPARISON RESULTS WERE 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. CUSTOMER WAS ADVISED OF PROPER TESTING TECHNIQUE AND NOT TO USE ALCOHOL PADS. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 135 MG/DL AND 136 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/19/2018 AND OPEN VIAL DATE IS A FEW DAYS AT TIME OF CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7535121 ↗
• MalfunctionMay 22, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS NOT CONCERNED WITH RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING SLUGGISH, FREQUENT URINATION AND EXCESSIVE THIRST. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BASEMENT. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER ORIGINALLY CALLED BECAUSE THEY WERE GETTING E-5 ERROR MESSAGES. WHILE TROUBLESHOOTING THE METER, CUSTOMER RECEIVED A READING OF HI. CUSTOMERS EXPECTED REGULAR FASTING RANGE IS 200MG/DL. CUSTOMER IS EXPERIENCING SYMPTOMS OF HIGH BLOOD SUGAR RESULTS. CUSTOMER STATES SHE IS NOT CONCERNED WITH HER METER BECAUSE SHE IS HAVING PROBLEMS WITH HER BLOOD SUGAR AND STATES THAT IT DOES FLUCTUATE. CUSTOMER IS NOT CONCERNED WITH HIGHER READINGS OR ERRATIC READINGS.

  Patient problems: Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 7532087 ↗
• MalfunctionMay 3, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. MEDICAL OFFICE STAFF MEMBER IS CALLING TO REPORT TRUEMETRIX AIR METER READ HI. STAFF MEMBER WAS INFORMED TRUEMETRIX AIR METER WAS NOT FOR MULTI-PATIENT USE AND WAS OFFERED UPGRADE TO TRUE METRIX PRO. STAFF MEMBER DECLINED REPLACEMENT STATING SHE WOULD SPEAK WITH DOCTOR REGARDING METER NOT BEING FOR MULTI-PATIENT USE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/21/2018 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. FACILITY CALLED IN AND STATES THE METER IS READING HI. I INFORMED THE STAFF MEMBER THAT I WOULD REPLACE THE METER DUE TO HI AND UPGRADE THE METER TO TRUEMETRIX PRO DUE TO THEIR CURRENT METER NOT BEING COMPATIBLE FOR MULTI-PATIENT. STAFF REFUSED THE REPLACEMENT AND WILL SPEAK TO THE DOCTOR REGARDING THE METER NOT BEING FOR MULTI-PATIENT USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7482819 ↗
• MalfunctionMar 29, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  CONSUMER INITIALLY REPORTED COMPLAINT FOR DEAD METER. HOWEVER ON FOLLOW UP CALL ON 3/13/2018 HE REPORTED SYMPTOMS AND MEDICAL ATTENTION. CUSTOMER STATES THAT ON (B)(6) 2018, HE HAD TAKEN BLOOD RESULT ON OLD METER (TA0408337) AND IT WORKED. LATER ON, HE TOOK HIS REGULAR MEDICATION OF HUMOLOG AND LANTUS. HIS WIFE FOUND CUSTOMER UNRESPONSIVE AND SHE CALLED OUT TO HIM AND NO RESPONSE. HE WAS SWEATY AND CLAMMY. THE PARAMEDICS WERE CALLED BETWEEN 11:00 PM AND 12:00 AM. THEY CAME WITHIN 5 MINUTES. . PARAMEDICS CAME, AND TOOK HIS BLOOD SUGAR AND THE RESULT WAS 27 MG/DL. HE WAS GIVEN IV WITH SUGAR AND THEN HE WAS OK WITHIN 10 MINUTES. THEY ASK HIM QUESTIONS AND HE WAS ABLE TO ANSWER. THE PARAMEDICS TOOK HIS BLOOD RESULT BEFORE LEAVING AND THE RESULT WAS ABOVE 100 MG/DL. HE DID NOT GO TO THE HOSPITAL. HIS WIFE LATER GAVE HIM 2 PEANUT BUTTER SANDWICHES. CUSTOMER NORMALLY TAKES THIS MEDICATION 4X A DAY ON A SLIDING SCALE. CUSTOMER SAYS HE CALLED THEM DUE TO HIS DIABETES. NO DIABETIC SYMPTOMS NOW AND HE IS FEELING WELL. ON THE (B)(6) HE TRIED TO TEST WITH OLD METER AND IT WAS DEAD. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 83 MG/DL. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE

  Patient problems: Fainting; Loss of consciousness; Sweating

  MAUDE report 7383816 ↗
• MalfunctionMar 19, 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 152, 17 0AND 190 MG/DL. CUSTOMER IS ALSO CONCERNED WITH NON-FASTING RESULTS OF 270 AND 277 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 - 130 MG/DL; AN EXPECTED NON-FASTING 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 ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 270 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/31/2018 AND OPEN VIAL DATE IS 02/25/2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): (B)(6). TIME IS NOT CORRECT ON METER. FIRST TWO READINGS ARE FROM THIS MORNING NON FASTING. CUSTOMER EDUCATED ON NON FASTING RESULTS AND IS STILL CONCERNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7351246 ↗
• MalfunctionFeb 26, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE RESULTS. SPOUSE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 106 AND 266MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 115 TO 140MG/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 NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 1/21/2019 AND OPEN VIAL DATE IS LESS THAN 4 MONTHS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). TEST WERE MADE ON THE SAME HAND, DIFFERENT FINGER. UNKNOWN IF RESULTS ARE FASTING OR NON-FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7297872 ↗
• MalfunctionDec 6, 2017High 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 163, 208 AND 153MG/DL FASTING AND 235 AND 248MG/DL NON-FASTING. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 75 - 150 MG/DL; AN EXPECTED NON-FASTING 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 ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER AS THE CUSTOMER HAD JUST EATEN. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2018 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6) CUSTOMER CALLED IN STATES THE METER IS READING HIGH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7087287 ↗
• MalfunctionNov 21, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. CUSTOMER ALSO STATED RESULTS HAVE BEEN HIGH BUT IS MORE CONCERNED WITH RESULTS BEING ERRATIC. CUSTOMER STATED THAT HE TOOK MEDICATION SOMETIMES BECAUSE OF THE RESULTS HE WAS GETTING. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM FASTING BACK TO BACK BLOOD TESTS OF 48 AND 131 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 120 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6)2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER IS NOT CONCERNED WITH FASTING RESULTS OF 48 AND 64 MG/DL BEING LOW): (B)(6). CUSTOMER IS CONCERNED WITH THE 48 MG/DL AND THEN 131 MG/DL READING WITHIN 15 MINUTES. CUSTOMER SAYS THAT SINCE THE HURRICANE HIS READINGS HAVE BEEN ASTRONOMICALLY HIGHER. CUSTOMER WAS MORE CONCERNED HIS BLOOD S

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7051163 ↗
• MalfunctionNov 17, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR E-5 AND HI BLOOD GLUCOSE RESULTS.(B)(6) MOTHER, IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF HI AND E-5. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200 TO 250MG/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 THE CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM BUT SOMETIMES IN HER PURSE. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED.THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/30/2018 AND OPEN VIAL DATE WAS LAST WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 : HI MG/DL DATE: (B)(6) 2017 TIME: 6:43PM N- FASTING. RESULT 2 : 266MG/DL DATE: (B)(6) 2017TIME: 2:07PM N-FASTING. RESULT 3 : 407MG/DL DATE: (B)(6) 2017TIME: 1:05PM FASTING. RESULT 4 : 338MG/DL DATE: (B)(6) 2017TIME: 12:49PM FASTING. RESULT 5 : 194MG/DL DATE:(B)(6) 2017 TIME: 12:22 AM FASTING. MOTHER CALLED IN STATING THAT THE METER IS READING E-5. AFTER TROUBLESHOOTING FOR E-5, RESULTS WAS HI. ADVISED CALLER THAT THE BLOOD SUGAR MAY BE READING HIGHER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7042193 ↗
• MalfunctionNov 8, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 96 AND 173MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200MG/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 NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 4/30/18 AND OPEN VIAL DATE IS APPROXIMATELY ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1 : 297 MG/DL DATE: (B)(6) TIME: 4:06 PM FASTING, RESULT 2 : 280 MG/DL DATE: (B)(6) TIME: 4:06 PM FASTING, RESULT 3 : 96 MG/DL DATE: (B)(6) TIME: 12:01 PM FASTING , RESULT 4 : 173 MG/DL DATE: (B)(6) TIME: 12:01 PM FASTING , RESULT 5 : 170 MG/DL DATE: (B)(6) TIME: 8:46 PM FASTING. CUSTOMER STATES THAT HIS BLOOD GLUCOSE NORMALLY RUNS HIGH AND HE IS CONCERNED ABOUT THE BACK TO BACK RESULTS THAT HE PERFORMED IN WHICH THE RESULTS WERE ERRATIC. DATE AND TIME NOT CURRENTLY SET UP IN THE METER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7010626 ↗
• MalfunctionNov 3, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR E-5. THE E-5 ERROR OCCURRED AS SOON AS THE BLOOD SAMPLE WAS ABSORBED. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULT OF HI. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING DIZZY AND STATED THEY WOULD GO TO THE ER. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/17/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Dizziness; Polydipsia

  MAUDE report 6998970 ↗