TRUE METRIX AIR TRUE METRIX AIR self monitoring blood glucose meter (REF REA4066-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00011822590051), received between Dec 6, 2016 and Nov 16, 2018 — classified as 57 malfunctions.

The most frequently reported specific device problem is “High Test Results” (41 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 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 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 110 TO 128MG/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 PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 214 AND 181MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/20/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1:217MG/DL DATE: (B)(6) 2018 TIME:1:36PM FASTING; RESULT 2:238MG/DL DATE: (B)(6) 2018 TIME:1:35PM FASTING; RESULT 3:170MG/DL DATE: (B)(6) 2018 TIME:1:34PM FASTING; RESULT 4:221MG/DL DATE:(B)(6) 2018 TIME:11:16AM FASTING; RESULT 5:256MG/DL DATE: (B)(6) 2018 TIME:12:49PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8081102 ↗
• MalfunctionOct 24, 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 METER NOT GOING TO TEST MODE ACCOMPANIED BY SYMPTOMS. CUSTOMER INSERTS THE TEST STRIP INTO THE METER AND ONCE THE BLOOD IS ABSORBED IT DOES NOT GO INTO TEST MODE. CUSTOMER WAS USING CORRECT TESTING TECHNIQUE. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED SYMPTOMS OF FATIGUE AND NAUSEA. CUSTOMER STATED HE WOULD CONTACT HIS DOCTOR. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 115 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2019 AND OPEN VIAL DATE WAS UNDISCLOSED.

  Patient problems: Fatigue; Nausea

  MAUDE report 8000353 ↗
• MalfunctionOct 17, 2018Incorrect, 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 TESTS RESULTS FROM RESULTS OBTAINED OF 148 AND 216 MG/DL, AND FROM FASTING BACK TO BACK BLOOD TESTS OF 72 AND 145 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 125 MG/DL. CUSTOMER STATED SHE HAS ONLY BEEN USING THE TRUEMETRIX AIR METER SINCE (B)(6). 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, THE CUSTOMER WAS UNABLE TO PERFORM A BACK TO BACK BLOOD TEST. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/20/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER STATES THAT SHE HAVE ONLY BEEN USING THE METER SINCE (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7975352 ↗
• MalfunctionJul 24, 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 199, 275, 230 AND 343 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 166 - 170 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 BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/29/2019 AND OPEN VIAL DATE IS MORE THAN THREE MONTHS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :199MG/DL DATE: (B)(6) 2018 TIME:8:49 AM FASTING; RESULT 2 :275MG/DL DATE: (B)(6) 2018 TIME:8:04AM FASTING; RESULT 3 :230MG/DL DATE: (B)(6) 2018 TIME:8:03AM FASTING; RESULT 4 :343MG/DL DATE: (B)(6) 2018 TIME:12:18PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7714793 ↗
• MalfunctionJul 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 297, 320, 374, 378 AND 384 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 140 MG/DL. CUSTOMER JUST STARTED TO USE THE TRUEMETRIX AIR METER THREE WEEKS AGO. 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 314 MG/DL AND 327 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 09/27/2019 AND OPEN VIAL DATE IS ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): (B)(6). CUSTOMER STATES THAT THE METER IS READING HIGH . CUSTOMER STATES THAT BEFORE HE STARTED TO USE THIS METER 3 WEEKS AGO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7702648 ↗
• MalfunctionJul 5, 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 207 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 105 - 140 MG/DL. CUSTOMER WAS NOT USING PROPER TESTING TECHNIQUE AND WAS USING ALCOHOL PADS. 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 COULD NOT FIND LANCING DEVICE AND COULD NOT PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL ON (B)(6) 2018. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. 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 1:106MG/DL DATE: (B)(6) TIME:519P FASTING, RESULT 2:113MG/DL DATE: (B)(6) TIME:5:15P FASTING, RESULT 3:130MG/DL DATE: (B)(6) TIME:10:20P FASTING, RESULT 4:132MG/DL DATE: (B)(6) TIME:10:19A FASTING, RESULT 5:207MG/DL DATE: (B)(6) TIME:1:42P FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7664080 ↗
• MalfunctionJun 22, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED HAVING INCREASED THIRST AND INCREASED URINATION. THE CUSTOMER DID NOT NEED MEDICAL ATTENTION AT THE TIME OF THE CALL. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF HI AND HI USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2019 AND OPEN VIAL DATE IS THREE DAYS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: HI, DATE:(B)(6) 2018, TIME:12:30PM, FASTING.

  Patient problems: Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 7629969 ↗
• MalfunctionJun 15, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  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 FATIGUE, BLURRED VISION, FEELING DIZZY. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2018 BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER WAS UNABLE TO ANSWER ANY FURTHER QUESTIONS DUE TO SYMPTOMS.

  Patient problems: Blurred Vision; Dizziness; Fatigue

  MAUDE report 7605616 ↗
• MalfunctionMay 23, 2018High 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 E-5 ACCOMPANIED BY SYMPTOMS. BROTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF VOMITING. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2019 AND OPEN VIAL DATE IS UNDISCLOSED. BROTHER CALLED IN WITH E-5 ERROR MESSAGES AS SOON AS THE STRIP IS INSERTED (8 TIMES). BROTHER DOES NOT WISH TO TROUBLESHOOT FURTHER AND EXPLAINED TO HIM THAT THE E-5 MEANS THE POSSIBILITY OF HIS BROTHER'S GLUCOSE COULD HE ELEVATED. BROTHER STATES CUSTOMER IS VOMITING AND HE WILL CALL THE PARAMEDICS AND WE WILL FOLLOW UP IN 24 HOURS.

  Patient problems: Hyperglycemia; Vomiting

  MAUDE report 7536859 ↗
• MalfunctionApr 5, 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 421, 191, 422, AND 322 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 130 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL 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 12/22/2018 AND OPEN VIAL DATE IS ONE MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7398952 ↗
• MalfunctionMar 27, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. STEPFATHER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-180MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF HEADACHE AND NAUSEA. 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 KITCHEN. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF HI USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/25/2018 AND OPEN VIAL DATE IS A FEW WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1 : HI DISPLAY DATE: (B)(6) 2018 TIME:10:11AM FASTING; RESULT 2 :372MG/DL DATE: (B)(6) 2018 TIME:8:33AM FASTING; RESULT 3 :447MG/DL DATE: (B)(6) 2018 TIME:7:48PM FASTING; RESULT 4 :280MG/DL DATE: (B)(6) 2018 TIME:4:41PM FASTING; RESULT 5 :523MG/DL DATE: (B)(6) 2018 TIME:2:36PM FASTING. CUSTOMER'S STEPDAD STATES THE METER READ E-5 AND HI DISPLAY TODAY WHILE CUSTOMER WAS AT SCHOOL. STEPDAD WANTED TO KNOW THE DIFFERENCE BETWE

  Patient problems: Headache; Nausea

  MAUDE report 7373517 ↗
• MalfunctionMar 27, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-0 AFTER BLOOD SAMPLE IS ABSORBED ACCOMPANIED BY SYMPTOMS. NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING DIZZY. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS AT THE TIME OF THE CALL. 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-0 TRUEMETRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2018 AND OPEN VIAL DATE IS (B)(6) 2010. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Dizziness; Fainting

  MAUDE report 7373014 ↗
• MalfunctionMar 22, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. GRANDSON IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF HI, 336 AND 202 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 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 STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED NON- FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 508 AND 493 MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 4/24/2019 AND OPEN VIAL DATE IS ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7363368 ↗
• MalfunctionFeb 22, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 BLOOD GLUCOSE RESULTS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF HEADACHE, NAUSEA, EXCESSIVE THIRST, EXCESSIVE URINATION AND EXCESSIVE HUNGER. MEDICAL ATTENTION IS 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-3 USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/22/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Blurred Vision; Headache; Polydipsia

  MAUDE report 7288733 ↗
• MalfunctionFeb 15, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED RESULTS OBTAINED OF 331MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-140MG/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 STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE LIVINGROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 255 AND 220MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/30/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1 :237MG/DL DATE: (B)(6) 2018 TIME:8:15AM FASTING, RESULT 2 :302MG/DL DATE: (B)(6) 2018 TIME:8:14AM FASTING, RESULT 3 :331MG/DL DATE: (B)(6) 2018 TIME:9:45PM FASTING, RESULT 4 :93MG/DL DATE: (B)(6) 2018 TIME:1:03PM FASTING, RESULT 5 :150MG/DL DATE: (B)(6) 2018 TIME:7:16AM FASTING, CUSTOMER CALLED IN STATES THE METER IS READING HIGH. CUSTOMER STATES THE METER READ 331MG/DL FASTING. CUSTOMER STATES HIS NORMAL FASTING RANGE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7272927 ↗
• MalfunctionFeb 12, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS PERFORMED NON-FASTING OF 400 AND 100 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 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 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 BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/30/2018 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLING STATES THAT THE METER IS GIVING ERRATIC RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7263285 ↗
• MalfunctionJan 29, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS. A NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED 94 AND 51MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 100MG/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 01/31/2019 AND OPEN VIAL DATE IS DECEMBER 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7226050 ↗
• MalfunctionJan 26, 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 346, 339, 280, 298 AND 285 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 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 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 02/16/2019 AND OPEN VIAL DATE AT TIME OF CALL 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 7221302 ↗
• MalfunctionDec 29, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING SWEATY AND DIZZY; CUSTOMER WAS GOING TO SEEK MEDICAL ATTENTION. 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 05/14/2018 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER CALLED IN STATES THE METER IS READING HI. . CUSTOMER STATES THE NEED FOR MEDICAL ATTENTION AT THE TIME OF CALL AND IS HAVING SIGNS AND SYMPTOMS OF HYPERGLYCEMIA AT THE TIME OF CALL.

  Patient problems: Dizziness; Sweating

  MAUDE report 7154608 ↗
• MalfunctionDec 5, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. (B)(6), 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 160 TO 180MG/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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/13/2017 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :249MG/DL DATE:(B)(6) 2017 TIME:12:57AM FASTING, RESULT 2 :261MG/DL DATE:(B)(6) 2017 TIME:12:56AM FASTING, RESULT 3 :370MG/DL DATE:(B)(6) 2017 TIME:05:23PM FASTING, RESULT 4 :292MG/DL DATE:(B)(6) 2017 TIME:05:22PM FASTING, RESULT 5 :210MG/DL DATE:(B)(6) 2017 TIME:10:02PM FASTING. CUSTOMER CALLED IN STATES THE METER IS READING ERRATIC AND CUSTOMER IS CONCERNED THAT THE RESULTS ARE HIGH. CUSTOMER STATED HIS WIFE WAS GIVEN A TRUE METRIX METER FROM INSURANCE COMPANY. CUSTOMER STATED THAT THE METER WAS READING ERRATIC BACK TO BACK RESULTS. CUSTOMER STATED, DUE TO RESULT FROM METE

  Patient problems: Hypoglycemia

  MAUDE report 7082843 ↗
• MalfunctionNov 17, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 120 MG/DL OR UNDISCLOSED. 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 HALLWAY. 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 99 AND 107 MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/13/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER DOES NOT HAVE HYPERGLYCEMIC AND HYPOGLYCEMIC SYMPTOMS AT THIS TIME. CUSTOMER DOES NOT NEED MEDICAL ATTENTION. CUSTOMER IS COMPLAINING OF LOW RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7041161 ↗
• MalfunctionNov 2, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 271, 226, 254, 171 AND 208 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS LESS THAN 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 11/25/2018 AND OPEN VIAL DATE AT TIME OF CALL IS TWO WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 : 271 MG/DL DATE: 10/11 TIME: 1:30 PM FASTING, RESULT 2 : 226 MG/DL DATE: 10/11 TIME: 1:30 PM FASTING, RESULT 3 : 254 MG/DL DATE: 10/11 TIME: 1:29 PM FASTING, RESULT 4 : 171 MG/DL DATE: 10/10 TIME: 5:32 PM FASTING, RESULT 5 : 208 MG/DL DATE: 10/10 TIME: 5:31 PM FASTING. CUSTOMER STATES THAT RESULTS ARE HIGHER THAN HIS NORMAL RANGE FASTING AS WELL AS BACK TO BACK BLOOD TESTS THAT HE PERFORMED WERE ON THE ERRATIC SIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6996467 ↗
• MalfunctionOct 27, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH METER TO METER COMPARISON AND ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150MG/DL. THE CUSTOMER FEELS WELL DID NOT REPORT SYMPTOMS OF SYMPTOM. 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 NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 8/23/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (DATE/TIME NOT STORED CORRECTLY): RESULT 1 : 273 MG/DL DATE: (B)(6) 2017 TIME: 8 AM FASTING, RESULT 2 : 211 MG/DL DATE: (B)(6) 2017 TIME: 12 PM (NON), RESULT 3 : 269 MG/DL DATE: (B)(6) 2017 TIME: 6 PM (NON), RESULT 4 : 315 MG/DL DATE: (B)(6) 2017 TIME: 10 PM (NON), RESULT 5 : 289 MG/DL DATE: (B)(6) 2017 TIME: 8 AM (FASTING). THE CUSTOMER IS NOT HAVING ANY DIABETIC SYMPTOMS. THE DIAGNOSIS AT THE HOSPITAL WAS DIABETIC KETOACIDOSIS (NOT DUE TO THE USE OF THE METER). AT THE HOSPITAL, THE CUSTOMER RECEIVED REGULAR PROTOCOL FOR T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6985058 ↗
• MalfunctionOct 20, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM METER MEMORY OF 200 AND 250 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 150 MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER STATED THAT ON (B)(6) 2017 SHE HAD BEEN FEELING SHAKY AND HAD TO SEEK MEDICAL ATTENTION FROM URGENT CARE. THE URGENT CARE DIAGNOSIS WAS LOW BLOOD SUGAR. THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN AT URGENT CARE WAS 50 MG/DL. THE CUSTOMER HAD PERFORMED A BLOOD TEST WITH TRUEMETRIX AIR METER AND OBTAINED A RESULT OF 200 MG/DL; TESTS WERE NOT PERFORMED BACK TO BACK. THE CUSTOMER WAS GIVEN ORANGE JUICE AND GLUCOSE TABLETS TO RAISE HER BLOOD SUGAR. THERE WERE NO NEW MEDICATIONS OR HEALTHCARE PROGRAM SUGGESTED. THE CUSTOMER LEFT URGENT CARE ON (B)(6) 2017. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 83 MG/DL AND 120 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE

  Patient problems: Shaking/Tremors

  MAUDE report 6965506 ↗
• MalfunctionOct 18, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM METER MEMORY OF ERRATIC NON-FASTING BACK TO BACK TESTS OF 150 AND 198 MG/DL AND HIGH FASTING RESULTS OF 154, 184, 163, AND 149 MG/DL. CUSTOMER WAS ALSO COMPARING RESULTS TO ANOTHER DEVICE; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85-130 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 ON (B)(6) 2017, 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 04/30/2018 AND OPEN VIAL DATE AT TIME OF CALL IS LESS THAN ONE MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 : 198MG/DL DATE: (B)(6) 2017 TIME: 12:03PM NONFASTING; RESULT 2 : 150MG/DL DATE: (B)(6) 2017 TIME: 11:58AM NONFASTING ; RESULT 3 : 139MG/DL DATE: (B)(6) 2017 TIME: 6:47AM FASTING; RESULT 4 : 154MG/DL DATE: (B)(6) 2017 TIME: 3:43PM FASTING; RESULT 5 :

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6957996 ↗