TRUE METRIX AIR TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE SYSTEMRecalls & reported problems

Summary

The FDA's MAUDE database contains 169 adverse event reports that list this exact device (DI 00021292007584), received between Nov 29, 2016 and Jan 3, 2019 — classified as 169 malfunctions.

The most frequently reported specific device problem is “High Test Results” (105 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 169 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS ACCOMPANIED BY SYMPTOMS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF (B)(4) AND 141MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 120MG/DL. THE CUSTOMER DID REPORT SYMPTOM OF FEELING TIRED. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6)2018 A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF (B)(4) AND 158MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS (B)(6)2020 AND OPEN VIAL DATE IS (B)(6)2018 . THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:141MG/DL DATE:(B)(6)2018 TIME:9:52 AM FASTING RESULT 2:114MG/DL DATE:(B)(6)2018 TIME:9:50 AM FASTING RESULT 3:89MG/DL DATE:(B)(6)2018 TIME:11:39 PM FASTING RESULT 4:79MG/DL DATE:(B)(6)2018 TIME:11:37 PM FASTING RESULT 5:110MG/DL DATE:(B)(6)2018 TIME:5:39 PM FASTING CUSTOMER CALLED IN STATES THE METER IS READING ERRATIC. CUSTOMER STATES THE METER READ 114MG/DL

  Patient problems: Fatigue

  MAUDE report 8213061 ↗
• MalfunctionJan 2, 2019High Test Results; Low Test Results; High Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 377, 366 AND 297MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS ON DATE OF CALL. 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 ON (B)(6) 2018, A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/27/2020, AND OPEN VIAL DATE IS (B)(6)2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED IN STATING THAT THE METER IS NOT WORKING. ON SUNDAY, (B)(6) 2019, THE CUSTOMER WOKE-UP IN THE MIDDLE OF THE NIGHT FEELING SICK (DIZZY, LETHARGIC), THE WIFE STATES THAT THE CUSTOMER FELL OFF THE BED WHILE TRYING TO GO TO THE BATHROOM, CUSTOMER WAS LETHARGIC, DIZZY AND CONFUSED. WIFE CALLED 911 AND THE PARAMEDICS CAME. THROUGHOUT THE PROCESS, CUSTOMER DID NOT CHECK HIS BLOOD SUGAR WITH THE TRUE METRIX AIR. THE PARAMEDICS CHECK HIS BLOOD SUGAR WITH THEIR METER AND THE RESULTS WAS 27 MG/DL FASTING. CUSTOM

  Patient problems: Confusion/ Disorientation; Dizziness; Hypoglycemia

  MAUDE report 8209982 ↗
• MalfunctionDec 21, 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 91 AND 380 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 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) 2018, A BACK-TO-BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 216 MG/DL AND 187 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 10/23/2019, AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (ERRATIC RESULTS WERE THE CUSTOMER'S MAIN CONCERN): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8189145 ↗
• MalfunctionDec 13, 2018Failure to Power Up; Failure to Power Up

  CONSUMER REPORTED COMPLAINT FOR DEAD METER ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING WEAK AND HAVING SHAKY HANDS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. PRODUCT STORAGE LOCATION IS UNDISCLOSED THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. METER DOES NOT TURN ON. METER DOES NOT TURN ON WHEN THE TEST STRIPS ARE INSERTED AND WHEN THE WHITE DOT IS PRESSED. CUSTOMER STATES THAT SHE FEELS WEAK AND HER HANDS ARE SHAKING. CUSTOMER FEELS PHYSICALLY WEAK, SHE STATES THAT EVERY TIME SHE FINISHES WALKING SHE FEELS WEAK.

  Patient problems: Shaking/Tremors; Weakness

  MAUDE report 8161456 ↗
• MalfunctionDec 6, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. FRIEND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF HI. FRIEND ALSO STATED THAT THE TRUE METRIX AIR METER WAS READING ABOUT 30 PTS HIGHER THAN FRIEND'S METER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 460 - 493 MG/DL. FRIEND STATED CUSTOMER HAS BEEN ON PREDNISONE FOR MANY YEARS. FRIEND STATED THE CUSTOMER'S HHN NURSES SEE HER REGULARLY AND ARE AWARE OF THE METERS READINGS AND THAT SO IS HER DOCTOR. 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 DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/27/2020 AND OPEN VIAL DATE IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). COMPLAINT DETAILS HER FRIEND PATRICE CALLED ABOUT METER READING DIFFERENT THEN HER METER, ABOUT 30 PTS HIGHER BUT CUSTOMER IS RUNNING HIGH R

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8139489 ↗
• MalfunctionNov 20, 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. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT SHE WAS GOING TO CALL HER DOCTOR IN ORDER TO DETERMINE HOW MUCH MEDICATION TO TAKE. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8089948 ↗
• MalfunctionNov 9, 2018Failure to Power Up; Failure to Power Up

  CONSUMER REPORTED COMPLAINT FOR DEAD METER FOLLOWED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. CUSTOMER DID REPORT SYMPTOMS. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/21/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER IS WELL AT TIME OF INITIAL CALL. METER DOES NOT TURN ON AT ALL. BATTERY WAS INSERTED CORRECTLY. A FOLLOW UP CALL WAS MADE ON (B)(6) 2018; WHILE WAITING ON TRIVIDIA METER TO ARRIVE, CUSTOMER STATES HER GLUCOSE DROPPED ON (B)(6) 2018. CUSTOMER WAS EXPERIENCING SYMPTOMS AND CALLED THE PARAMEDICS. CUSTOMER STATES THE PARAMEDICS ARRIVED AND HER BLOOD GLUCOSE WAS 32MG/DL FASTING. THE PARAMEDICS ADMINISTERED GLUCOSE IV. CUSTOMER IS STABLE NOW AND STATES SHE WILL DISCARD HER OLD METER. CUSTOMER STATES SHE FELT HER NORMAL SYMPTOMS (NOT SPECIFIED) OF LOW GLUCOSE AND DECIDED TO CALL PARAMEDICS. CUSTOMER HAD NO SYMPTOMS AT TIME OF CALL AND DOES NOT REQUIRE AND MEDICAL ATTENTION AT THIS TIME

  Patient problems: Hypoglycemia

  MAUDE report 8056342 ↗
• MalfunctionNov 6, 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 212 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 150 MG/DL. CUSTOMER WAS ALSO CONCERNED RESULTS IN THE METER MEMORY WERE ERRATIC, BUT TESTS WERE NOT REPORTED AS BEING PERFORMED BACK TO BACK. 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. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2020 AND OPEN VIAL DATE IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:86MG/DL DATE:(B)(6) 2018 TIME:1001AM FASTING, RESULT 2:211MG/DL DATE:(B)(6) 2018TIME:1106AM NON FASTING, RESULT 3:90MG/DL DATE: (B)(6) 2018 TIME:653AM FASTING, RESULT 4:212MG/DL DATE: (B)(6) 2018 TIME:231PM FASTING, RESULT 5:118MG/DL DATE: (B)(6) 2018 TIME:730AM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8043872 ↗
• MalfunctionNov 5, 2018Battery Problem; Battery Problem

  CONSUMER REPORTED COMPLAINT FOR DEAD METER. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING NAUSEOUS AND DIZZY. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE METER DID NOT TURN ON WHEN A TEST STRIP WAS INSERTED OR BY MANUALLY PRESSING THE S BUTTON. CUSTOMER WAS USING THE CORRECT TEST STRIPS AND TEST STRIP WAS INSERTED CORRECTLY. THE BATTERY WAS INSTALLED PROPERLY. NO NEW BATTERY WAS USED. CUSTOMER WAS GOING TO PURCHASE A NEW BATTERY. CUSTOMER DECLINED REPLACEMENT.

  Patient problems: Dizziness; Nausea

  MAUDE report 8039927 ↗
• MalfunctionOct 17, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 124 - 160 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 CUSTOMER DECLINED TO 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 02/15/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7974781 ↗
• MalfunctionOct 3, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 263, 275, 195, 209 AND 229 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 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 ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 242 MG/DL AND 237 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 10/23/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER COULD NOT REALLY SEE THE DATE/TIME, AND SO HE PROVIDED THE INFORMATION HE THINKS HE SEES; ALSO CUSTOMER STATED THAT HE HAS NEVER SET UP THE DATE/TIME): RESULT 1 :263MG/DL DATE: (B)(6) 2018 TIME: 01:00PM FASTING; RESULT 2 :275MG/DL DATE: (B)(6) 2018 TIME: 01:00PM FASTING; RESULT 3 :195MG/DL DATE: (B)(6) 2018 TIME: 03:00PM FASTING; RESULT 4 :209MG/DL DATE: (B)(6) 2018 TIME: 04:00AM FASTING; RESULT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7931525 ↗
• MalfunctionOct 1, 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 ERROR: TEST STRIP ERROR. THE E-5 ERROR OCCURRED AFTER THE BLOOD SAMPLE HAD BEEN APPLIED. CUSTOMER STATED HE HAD TRIED TO PERFORM SIX BLOOD GLUCOSE TESTS AND HAD OBTAINED THE E-5 ERROR SIX TIMES. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING TIRED AND THAT HE BELIEVED HIS BLOOD GLUCOSE WAS HIGH. CUSTOMER STATED THAT HE HAS BEEN FEELING THAT WAY FOR TWELVE HOURS. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER DECLINED TO PERFORM A BLOOD TEST DURING THE CALL ON (B)(6) 2018. CUSTOMER HAD DISCONNECTED THE CALL.

  Patient problems: Fatigue

  MAUDE report 7923522 ↗
• MalfunctionSep 18, 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 336, 334, 242, 270 AND 229 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 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 PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 149 MG/DL AND 174 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 12/26/2018 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 7885445 ↗
• MalfunctionSep 14, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO DISPLAY. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF LO (TRUE MANGER AIR APP). THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 -120MG/DL. THE CUSTOMER FEELS WELL AND 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 BY CUSTOMER ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/17/2019 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) (NOT IN THE METER BUT ON THE TRUE MANGER AIR APP).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7877970 ↗
• MalfunctionSep 13, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 55 MG/DL. THE CUSTOMER ALSO STATED THAT SHE HAD OBTAINED RESULTS IN THE 60'S BUT THOSE RESULTS COULD NOT BE FOUND IN THE METER MEMORY. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 - 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 CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING AREA. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/27/2018 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 7873120 ↗
• MalfunctionSep 7, 2018Low Test Results; Adverse Event Without Identified Device or Use Problem; Low Test Results; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. HUMANA REPRESENTATIVE, WITH CUSTOMER ON THE LINE, IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 40 MG/DL FASTING AND METER TO LAB COMPARISON RESULTS OF 104 MG/DL NON-FASTING USING TRUEMETRIX AIR METER AND 285 MG/DL NON-FASTING FROM DOCTOR'S LAB. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 100 MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT IN (B)(6) (CUSTOMER DID NOT REMEMBER EXACT DATE) HAD FELT DIZZY AND LIGHTHEADED. CUSTOMER HAD PERFORMED A BLOOD TEST FASTING USING THE TRUEMETRIX AIR METER AND OBTAINED A RESULT OF 60 MG/DL. CUSTOMER STATED SHE HAD GONE TO THE ER. CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AND WAS GIVEN ORANGE JUICE. CUSTOMER DID NOT REMEMBER HER BLOOD GLUCOSE TEST RESULT WHEN AT THE ER. THE ER DOCTOR HAD ADVISED THE CUSTOMER TO STOP TAKING METFORMIN AND VICTOZA. CUSTOMER WAS AT THE ER FOR TWO HOURS BEFORE BEING RELEASED THE SAME DAY. CUSTOMER HAD CONTINUED TO USE THE TRUEMETRIX AIR METER. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER

  Patient problems: Dizziness; Hypoglycemia

  MAUDE report 7857007 ↗
• MalfunctionSep 5, 2018High Test Results; Low Test Results; High Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH METER TO METER COMPARISON OF 155MG/D USING THE TRUE METRIX METER VS 41MG/DL USING THE EMT METER AND RESULT OBTAINED OF 55 AND 43MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 120MG/DL. THE CUSTOMER FEELS WELL AND DID REPORT SYMPTOMS. 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/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 120 AND 122MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 3/31/2019 AND OPEN VIAL DATE IS APPROXIMATELY THREE WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1 :130MG/DL DATE: (B)(6) 2018 TIME:10:43PM FASTING; RESULT 2 :43MG/DL DATE: (B)(6) 2018 TIME:5:48AM FASTING; RESULT 3 :120MG/DL DATE: (B)(6) 2018 TIME:5:56PM N/FASTING; RESULT 4 :146MG/DL DATE: (B)(6) 2018 TIME:12:00AM FASTING; RESULT 5 :55MG/DL DATE: (B)(6) 2018 TIME:6:0

  Patient problems: Hypoglycemia; No Known Impact Or Consequence To Patient

  MAUDE report 7847911 ↗
• MalfunctionAug 28, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 36 AND 28MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-100MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS 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 BY CUSTOMER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 7/16/2019 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). BLOOD READINGS WHICH WAS NOT CONSISTENT TO HOW HE WAS FEELING WHICH WAS FINE (ASYMPTOMATIC). HE IS VERY ATTUNED TO HOW HE FEELS. THE METER READING IN THE 20'S AND 30'S WAS READING VERY LOW WITH NO SYMPTOMS AT ALL. HE NOW DOES NOT KNOW IF THE METER IS READING CORRECTLY AND HAS NO FAITH IN THE METER AND WANTS IT REPLACED. HE DOES NOT HAVE THE CORRECT DATE AND POSSIBLY THE TIME. CUSTOMER HAS BEEN USING THE METER FOR A WHILE WITH NO PROBLEME, UNTIL YESTERDAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7824148 ↗
• MalfunctionAug 16, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OBTAINED OF 160, 178, 194, 215 AND 165 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 - 130 MG/DL. CUSTOMER STATED HE COMPARED THE TRUEMETRIX AIR METER TO ANOTHER DEVICE AND THAT THE RESULTS ARE HIGHER; 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. 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 181 MG/DL AND 190 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE OFFICE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2019 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 7788864 ↗
• MalfunctionAug 8, 2018Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW AND ERRATIC BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 143 AND 167 MG/DL AND 155 AND 38 MG/DL; AND OF RESULTS OBTAINED OF 38 AND 39 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 128 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 AN OFFICE DESK DRAWER. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/17/2019 AND OPEN VIAL DATE IS UNKNOWN. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7763723 ↗
• MalfunctionAug 7, 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 TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 202 AND 122 MG/DL, 247 AND 179 MG/DL AND 202 AND 40 MG/DL. CUSTOMER WAS NOT CONCERNED WITH LOW OR HIGH RESULTS. THE RESULT OF 122 MG/DL COULD NOT BE CONFIRMED IN THE METER MEMORY. CUSTOMER STATED THAT RESULT HAD BEEN OBTAINED ONE MINUTE AFTER THE RESULT OF 202 MG/DL. CUSTOMER WAS USING CORRECT BACK TO BACK TESTING TECHNIQUE. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 180 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 09/19/2019 AND OPEN VIAL DATE IS 07/02/2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7759345 ↗
• MalfunctionJul 30, 2018Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT OF E-3 ERROR: USED TEST STRIP, TEST STRIP OUTSIDE OF VIAL TOO LONG, SAMPLE ON TOP OF TEST STRIP. THE E-3 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. DURING THE CALL ON (B)(6) 2018 THE CUSTOMER REPORTED FEELING SHAKY, BUT WAS NOT SURE IF IT WAS DUE TO DIABETES OR HIS PARKINSON'S DISEASE. CUSTOMER DID NOT NEED MEDICAL ATTENTION AT THE TIME OF THE CALL. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (B)(6) 2018 AS A RESULT OF THE METER'S READINGS. BLOOD TEST PERFORMED DURING CALL ON (B)(6) 2018 PRODUCED RESULT OF E-3 ERROR. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2019 AND OPEN VIAL DATE WAS UNDISCLOSED. ADVERSE EVENT NOT REPORTED AT TIME OF CALL. CUSTOMER REQUESTED TO BE CALLED BACK ON (B)(6) 2018 AFTER HE WENT TO A PREVIOUSLY SCHEDULED DOCTOR'S APPOINTMENT. AT CALL BACK, CUSTOMER'S CONDITION HAD IMPROVED AND HE DID NOT CURRENTLY HAVE ANY DIABETIC SYMPTOMS. NO MEDICAL INTERVENTION SINCE THE LAST CALL WAS REPORTED. NO ADDITIONAL BLOOD TESTS WERE PERFORMED USING THE TRUEMETRIX AIR METER.

  Patient problems: Shaking/Tremors

  MAUDE report 7733037 ↗
• MalfunctionJul 25, 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 373 AND 232 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 98 - 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) 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 07/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE CUSTOMER DECLINED TO REVIEW THE METER MEMORY FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER DENIES THE NEED FOR MEDICAL ATTENTION AT THE TIME OF CALL AND DENIES SIGNS AND SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7720565 ↗
• MalfunctionJul 25, 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 211 AND 201 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 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. CUSTOMER ALSO STATED THAT HE ACCIDENTLY LEFT THE TEST STRIP VIAL IN THE CAR FOR A WHOLE DAY. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/13/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :159MG/DL DATE:(B)(6) 2018 TIME:07:36AM FASTING; RESULT 2 :211MG/DL DATE:(B)(6) 2018 TIME:05:06AM FASTING; RESULT 3 :201MG/DL DATE:(B)(6) 2018 TIME:05:05AM FASTING; RESULT 4 :189MG/DL DATE:(B)(6) 2018 TIME:09:38PM FASTING; RESULT 5 :182MG/DL DATE:(B)(6) 2018 TIME:02:32PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7720336 ↗
• MalfunctionJul 25, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER'S EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200 - 300 MG/DL; CUSTOMER NORMALLY TESTS 1 HOUR AFTER EATING IN THE EVENINGS. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. DAUGHTER STATED THAT THE NIGHT BEFORE CUSTOMER HAD PERFORMED A BLOOD TEST FASTING AND HAD OBTAINED A RESULT OF 282 MG/DL. DAUGHTER STATED BASED ON THE RESULT OF 282 MG/DL CUSTOMER HAD ADMINISTERED 8 UNITS OF INSULIN. WHEN CUSTOMER TESTED AGAIN NON-FASTING HE HAD OBTAINED BLOOD GLUCOSE TEST RESULTS OF 45, 40 AND 33 MG/DL. DUE TO THE LOW RESULTS, DAUGHTER HAD GIVEN HIM APPLESAUCE. CUSTOMER WAS ALSO NOT COHERENT AND HAD NO STRENGTH. DAUGHTER HAD CALLED EMS. EMS ARRIVED AND CUSTOMER'S BLOOD GLUCOSE TEST RESULT WITH THEIR METER WAS 35 MG/DL NON-FASTING. EMS HAD ADMINISTERED SUGAR TO THE CUSTOMER. CUSTOMER WAS CONCERNED THAT HIS GLUCOSE SHOULD NOT HAVE DROPPED SO LOW SO FAST AND WAS CONCERNED WITH THE NON-FASTING LOW 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 S

  Patient problems: Hypoglycemia; Weakness

  MAUDE report 7719937 ↗