TRUE METRIX AIR Publix true metrix air SELF-MONITORING BLOOD GLUCOSE METERRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00041415072787), received between Nov 30, 2016 and Nov 20, 2018 — classified as 34 malfunctions.

The most frequently reported specific device problem is “High Test Results” (19 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2018Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem; Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR E-5 ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF VOMITING, FREQUENT URINATION, EXCESS KETONES. 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 (B)(6) 2020 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Urinary Frequency / Polyuria; Vomiting

  MAUDE report 8090851 ↗
• MalfunctionNov 16, 2018Incorrect, 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 TESTS RESULTS FROM BACK TO BACK BLOOD TESTS OF 110 AND 23 MG/DL NON-FASTING. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 120 MG/DL. CUSTOMER ALSO CONCERNED WITH LOW RESULTS; AN EXPECTED NON-FASTING 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 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 10/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8080407 ↗
• MalfunctionOct 30, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 60, 47, 51 AND 45 MG/DL. CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 120 MG/DL. CUSTOMER HAS ONLY BEEN USING THE TRUEMETRIX AIR METER FOR A FEW WEEKS. 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, BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING AREA. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/23/2019 AND OPEN VIAL DATE IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8019422 ↗
• MalfunctionOct 1, 2018High Test Results; High Test Results

  CUSTOMER CALLED TO ORDER CONTROL SOLUTION AND STATED HER BLOOD SUGAR WAS READING HIGH. CUSTOMER WAS NOT CONCERNED WITH THE BLOOD GLUCOSE TEST RESULTS AS SHE STATED SHE WAS HAVING SYMPTOMS OF HIGH BLOOD GLUCOSE. CUSTOMER STATED SHE WAS FEELING DIZZY, HAVING NECK PAIN, FREQUENT URINATION AND THIRST. CUSTOMER STATED SHE WAS GOING TO SEEK MEDICAL ATTENTION. CUSTOMER ALSO STATED SHE HAD A STANDING DOCTOR'S APPOINTMENT THAT FRIDAY. CUSTOMER WAS UNABLE TO CONTINUE WITH THE CALL AND NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Dizziness; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 7923377 ↗
• MalfunctionSep 10, 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 UNKNOWN. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE LIVING ROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 447 AND 359MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2019 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). CUSTOMER CALLING IN STATING THE METER IS READING ERRATIC READINGS. CUSTOMER ALSO STATES METER IS READING HIGH READINGS IN THE MORNING. CUSTOMER IS TESTING FASTING. HOWEVER, CUSTOMER IS NOT DOING THE PROPER BACK TO BACK TESTING. CUSTOMER IS NOT SURE WHAT EXPECTED RANGE IS. CUSTOMER LAST A1C WAS IN FEB AT 9%. CUSTOMER DID HAVE RECENT CHANGES IN MEDICATION. ORAL DIABETIC MEDS WERE INCREASED. HOWEVER, CUSTOMER STATES READING A

  Patient problems: Hyperglycemia

  MAUDE report 7861600 ↗
• MalfunctionSep 4, 2018Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem; Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR E-3 ERROR CODE. THE E-3 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 128 MG/DL USING TRUEMETRIX AIR METER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE WAS NOT DISCLOSED. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING LIGHTHEADED, FATIGUED AND TIRED. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2019 AND OPEN VIAL DATE WAS NOT DISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Fatigue

  MAUDE report 7842079 ↗
• MalfunctionAug 13, 2018High 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 545, 293, 257, 203 AND 194 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 200 MG/DL. CUSTOMER STATED THAT HE PERFORMED THREE BLOOD TESTS AND HAD OBTAINED THE SAME RESULT OF 545MG/DL 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 ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 439 MG/DL AND 439 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2019 AND OPEN VIAL DATE IS ONE MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): (B)(6). CUSTOMER WANTS TO KNOW HOW TO RESET THE METER. CUSTOMER STATES THAT HE RUN 3 BLOOD TESTS AND GOT THE SAME RESULTS ALL THREE TIMES, 545MG/DL FASTING. CUSTOMER STATES THAT THE RESULTS WERE OVER 500, THE RESULTS ARE TOO HIGH. METER TIME AND DATE IS NOT SET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7776863 ↗
• MalfunctionAug 3, 2018Low 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 54, 65 AND 83 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 104 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED WHEN SHE OBTAINED THE LOW RESULTS SHE DID NOT HAVE 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 PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 105 MG/DL AND 113 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/23/2019 AND OPEN VIAL DATE IS TWO WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7748566 ↗
• MalfunctionJul 30, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 90, 55, 99 AND 83 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 102 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 PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 69 MG/DL AND 75 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/22/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7733078 ↗
• MalfunctionJul 26, 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 224, 280 AND 225 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 126 - 215 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 STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/22/2019 AND OPEN VIAL DATE IS A FEW DAYS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7724492 ↗
• MalfunctionMay 22, 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 140 TO 150MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE LIVING ROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 259 AND 259MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/20/2019 AND OPEN VIAL DATE IS LAST WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). CUSTOMER STATES THAT HE HAS BEEN USING THIS METER FOR OVER A YEAR, AND THE METER IS NOW READING TOO HIGH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7531756 ↗
• MalfunctionApr 25, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 42, 91 AND 98MG/DL. CUSTOMER STATES THAT HER METER IS READING 40-50 POINTS LOWER THAN THE OTHER BRAND. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130-145MG/DL. THE CUSTOMER FELT WELL AT THE TIME OF THE CALL. HOWEVER THE CUSTOMER DID REPORT SYMPTOM OF NOT FEELING WELL ON (B)(6) 2018 AND MEDICAL ATTENTION IS REPORTED AT THAT TIME AS A RESULT OF LOW BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY): RESULT 1:91MG/DL DATE: (B)(6) 2018 TIME:8:49AM FASTING; RESULT 2:144MG/DL DATE: (B)(6) 2018 TIME:11:11PM FASTING; RESULT 3:157MG/DL DATE: (B)(6) 2018 TIME:10:23PM FASTING; RESULT 4:130MG/DL DATE:(B)(6) 2018 TIME:9:39PM FASTING; RESULT 5:98MG/DL DATE: (B)(6) 2018 TIME:8:19PM FASTING. BACK IN (B)(6) CUSTOMER WAS FEELING SICK. CUSTOMER'S HUSBAND TOLD HER TO CALL AN AMBULANCE. CUSTOMER CHECK HER BLOOD SUGA

  Patient problems: Hypoglycemia

  MAUDE report 7462275 ↗
• MalfunctionMar 7, 2018High Test Results; High Test Results

  CONSUMER INITIALLY REPORTED COMPLAINT FOR TEST STRIP NOT RECOGNIZING OR TEST STRIP NOT ABSORBING THE BLOOD. CUSTOMER INSERTED THE TEST STRIP INTO THE METER AND ONCE THE BLOOD WAS ABSORBED IT DID NOT GO INTO TEST MODE. CUSTOMER WAS USING THE PROPER TESTING TECHNIQUE. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 337 MG/DL AND 333 MG/DL USING TRUEMETRIX AIR METER. CUSTOMER STATED THE RESULTS ARE HIGH. THE CUSTOMER IS ALSO CONCERNED WITH TESTS RESULTS FROM METER MEMORY OF 157 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 125 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 SPARE ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7322114 ↗
• MalfunctionMar 1, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS.THE CUSTOMER IS CONCERNED WITH THE RESULTS OBTAINED OF 317, 227 AND 219MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-130MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1 :141MG/DL DATE:(B)(6) 2018 TIME:11:01AM FASTING, RESULT 2 :217MG/DL DATE:(B)(6) 2018 TIME:11:03AM FASTING, RESULT 3 :122MG/DL DATE:(B)(6) 2018 TIME:06:09PM FASTING, RESULT 4 :227MG/DL DATE:(B)(6) 2018 TIME:11:18AM FASTING, RESULT 5 :219MG/DL DATE:(B)(6) 2018 TIME:07:02PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7306207 ↗
• MalfunctionFeb 15, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 184 AND 194MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 95 TO 135MG/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. 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 04/14/2019 AND OPEN VIAL DATE IS TWO WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:184 MG/DL DATE:(B)(6) TIME:5:07PM FASTING, RESULT 2:194 MG/DL DATE: (B)(6) TIME:5:01PM FASTING. CUSTOMER JUST RECEIVED THE METER, ATTEMPTED TO TEST AND THE METER DISPLAYED HIGH RESULT. CUSTOMER EXPECTED RANGE FASTING IS 95-135MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7272981 ↗
• MalfunctionFeb 7, 2018High Test Results; Device Displays Incorrect Message; High Test Results; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-0 BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. SISTER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 150 MG/DL. THE CUSTOMER DID REPORT SYMPTOM OF BEING UNRESPONSIVE. MEDICAL ATTENTION IS 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 BATHROOM. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 121 MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2018 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). PREVIOUSLY THE CUSTOMER HAD A KIDNEY TRANSPLANT, HER HEMATOCRIT WAS 26.9% AND SHE WAS DIAGNOSED WITH ANEMIA. METER WAS GIVING HER E-0 (ONCE THE BLOOD IS ABSORBED) LAST NIGHT AND CUSTOMER COULD NOT OBTAIN A READING. THIS MORNING, (B)(6) 2018, SISTER WOKE UP AND CUSTOMER WAS UNRESPONSIVE AND THE PARAMEDICS WERE CALLED. PARAMEDICS METER READ LO AND SHE WAS TAKEN TO THE HOSPITAL ON (B)(6) 2018 (BGR AT HOSPITAL IS UNKNOWN). CUSTOMER WA

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 7247989 ↗
• MalfunctionJan 16, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR: TEST STRIP ERROR. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE E-5 ERROR OCCURRED AS SOON AS THE BLOOD SAMPLE WAS ABSORBED. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. AT THE TIME OF THE CALL THE CUSTOMER REPORTED SYMPTOMS OF DRY MOUTH AND INCREASED URINATION. CUSTOMER WAS GOING TO GO TO THE HOSPITAL. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/22/2018 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Hyperglycemia; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 7195982 ↗
• MalfunctionDec 21, 2017Low 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 50 MG/DL FASTING. CUSTOMER STATED WHEN SHE WENT TO HER DOCTOR'S APPOINTMENT, THE RESULT OBTAINED WITH THE DOCTOR'S METER HAD BEEN 112 MG/DL FASTING. TESTS WERE NOT PERFORMED BACK TO BACK. CUSTOMER STATED SHE WAS NOT FEELING ANY SYMPTOMS WHEN THE RESULT OF 50 MG/DL HAD BEEN OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 115 - 125 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. CUSTOMER DID NOT HAVE TEST STRIPS WITH HER AT TIME OF CALL AND SO WAS NOT ABLE TO PROVIDE MANUFACTURER'S EXPIRATION DATE. THE OPEN VIAL DATE IS (B)(6) 2017 AND THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7140646 ↗
• MalfunctionDec 14, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 135 TO 145MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2019 AND OPEN VIAL DATE IS (B)(66 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1 :195MG/DL DATE: (B)(6) 2017 FASTING. RESULT 2 :188MG/DL DATE: (B)(6) 2017 FASTING. RESULT 3 :213MG/DL DATE: (B)(6) 2017 FASTING. RESULT 4 :207MG/DL DATE: (B)(6) 2017 FASTING. RESULT 5 :306MG/DL DATE: (B)(6) 2017 FASTING. CUSTOMER CALLED IN STATES THE METER IS READING HIGH. CUSTOMER DOES NOT HAVE CONTROL SOLUTION. DID NOT RUN A BACK TO BACK BLOOD TEST SINCE CUSTOMER NO LONGER HAS TEST STRIPS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7116479 ↗
• MalfunctionNov 21, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS.THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED RESULTS OF 575MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 145 TO 165MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 306 AND 374MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/20/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: -TRUE METRIX 331MG/DL DATE: (B)(6) 2017 TIME: 5:58PM NOT FASTING. - TRUE METRIX 392MG/DL DATE: (B)(6) 2017 TIME: 4:00PM NOT FASTING. - TRUE METRIX 306MG/DL DATE: (B)(6) 2017 TIME: 6:43PM NOT FASTING. - TRUE METRIX 374 MG/DL DATE (B)(6) 2017 TIME: 6:44PM NOT FASTING. CUSTOMER WENT TO HOSPITAL REGARDING HIGH READING OF 575 MG/DL FASTING. CUSTOMER AT HOSPITAL HAD A READING OF 499 MG/DL LAB FASTING. CUSTOMER WAS ADMITTED AND RELEASED ON (B)(6) 2017 FOR

  Patient problems: Hyperglycemia

  MAUDE report 7048739 ↗
• MalfunctionOct 24, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 106 TO 116 MG/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 09/18/2018AND OPEN VIAL DATE IS ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY): RESULT 1: 214 MG/DL DATE: (B)(6) 2017TIME: 2:25PM FASTING. RESULT 2: 197 MG/DL DATE: (B)(6) 2017 TIME: 2:05PM FASTING. RESULT 3: 257 MG/DL DATE: (B)(6) 2017 TIME: 1:56PM FASTING . RESULT 4: 129 MG/DL DATE: (B)(6) 2017 TIME: 10:03AM FASTING. RESULT 5: 146 MG/DL DATE: (B)(6) 2017 TIME: 9:59AM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6972903 ↗
• MalfunctionSep 28, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 66 MG/DL USING TRUEMETRIX AIR METER AND 157 MG/DL USING ANOTHER DEVICE. WIFE STATED THEY THEN STOPPED USING THE METER AFTER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 128 - 132 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 STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/30/2018 AND OPEN VIAL DATE AT TIME OF CALL IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 1:66MG/DL (B)(6) 2017 12:32 PM FASTING:YES. 2:68MG/DL (B)(6) 2017 12:30 PM FASTING:NO. 3:86MG/DL (B)(6) 2017 06:16 AM FASTING:YES. 4:65MG/DL (B)(6) 2017 07:41 PM FASTING:NO. 5:80MG/DL (B)(6) 2017 06:54 AM FASTING:YES. ALL THE BLOOD RESULTS ACCESSED IN THE MEMORY ARE RUNNING ON THE LOW SIDE. WIFE SAID HER HUSBAND DOES NOT RUN THAT LOW. WIFE DOES HER HUSBA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6900670 ↗
• MalfunctionAug 14, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT OF E-2 ERROR: SAMPLE NOT DETECTED OR USING WRONG TEST STRIP. THE E-2 ERROR OCCURRED AS SOON AS THE BLOOD SAMPLE WAS ABSORBED. DURING THE CALL ON (B)(6) 2017 THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (B)(6) 2017 AS A RESULT OF THE METER'S READINGS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. CUSTOMER WAS USING THE CORRECT TEST STRIPS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2017 AND OPEN VIAL DATE AT TIME OF CALL WAS WITHIN FOUR MONTHS OF OPENING. ADVERSE EVENT NOT REPORTED AT TIME OF CALL ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6791258 ↗
• MalfunctionJun 6, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR E-5 AND HI BLOOD GLUCOSE TEST RESULTS. A FRIEND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF E-5 AND HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING WEAK AND TIRED AND EXPERIENCING EXCESSIVE THIRST AND FREQUENT URINATION. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF HI USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/22/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. FRIEND IS CALLING ON BEHALF OF CUSTOMER. FRIEND STATES THAT CUSTOMER WAS USING A FREESTYLE METER AND HE WAS GETTING RESULTS OF HI. HE BELIEVED THAT THE FREESTYLE METER WAS NOT WORKING AND HE PURCHASED A TRUE METRIX AIR METER. TRUE METRIX AIR METER WOULD NOT GIVE THEM A RESULT IT CONTINUE TO READ E-5. INSTRUCTED CUSTOMER THAT AN E-5 MEANS THAT HI

  Patient problems: Hyperglycemia; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 6614899 ↗
• MalfunctionMay 1, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 306, 253 AND 311MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 100MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 107 AND 113 MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/15/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER IS CALLING ON BEHALF OF HER (B)(6) DAUGHTER. CUSTOMER'S DAUGHTER IS INSULIN DEPENDENT AND TESTS 3-4 TIMES A DAY. CUSTOMER IS GETTING ERRATIC RESULTS ON THE METER. POINT DIFFERENCE IS OVER 30 POINTS. AT 07:04:00 PM CUSTOMER TESTED HER DAUGHTER LESS THAN 2 HOURS AFTER DINNER AND RECEIVED A READING OF 54MG/DL. CUSTOMER SAYS AT THIS POINT SHE GAVE HER DAUGHTER A JUICE BOX A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6533835 ↗