TRUE METRIX AIR TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE METER (REF REA4H01-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00021292007010), received between Dec 8, 2016 and Dec 6, 2018 — classified as 47 malfunctions.

The most frequently reported specific device problem is “High Test Results” (29 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 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 ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF A HEADACHE. MEDICAL ATTENTION IS NOT 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 152MG/DL NON-FASTING USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/17/2020 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Headache

  MAUDE report 8137558 ↗
• MalfunctionNov 21, 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 120MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF HEADACHE AND FEELING WEAK. 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 04/30/2020 AND OPEN VIAL DATE IS LAST WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1:236MG/DL DATE:(B)(6) 2018 TIME:10:34PM FASTING; RESULT 2:218MG/DL DATE: (B)(6) 2018 TIME:6:52PM FASTING; RESULT 3:168MG/DL DATE:(B)(6) 2018 TIME:4:46PM FASTING; RESULT 4:189MG/DL DATE:(B)(6) 2018 TIME:2:36PM FASTING; RESULT 5:218MG/DL DATE:(B)(6) 2018 TIME:12:11 PM FASTING. CUSTOMER STATES THAT HER METER IS GIVING HIGHER THAN NORMAL RESULTS. CUSTOMER STATED THAT YESTERDAY (B)(6) 2018, SHE WAS FEELING VERY WEAK AND HAD A VERY BAD HEADACHE. CUSTOMER STATED THAT SHE TOOK HER BOLD GLUCOSE AND IT WAS IN THE 260'S(UNSURE OF ACTUAL RESULT) AND SHE KNEW FELT THAT THE METER WAS INCORREC

  Patient problems: Headache; Weakness

  MAUDE report 8095178 ↗
• MalfunctionNov 5, 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 HI DISPLAY. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. CUSTOMER DID REPORT SYMPTOMS OF EXCESSIVE THIRST AND FATIGUE. NO MEDICAL ATTENTION REPORTED AT THE TIME OF THE CALL 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 BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/28/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Fatigue; Polydipsia

  MAUDE report 8037945 ↗
• MalfunctionOct 1, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 175, 197, 264 AND 261MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF BLURRY VISION, FEELING FATIGUE AND SHAKY. 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 CLOSET. 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 230 AND 245MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/19/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER STATES THAT HE FEELS ILL- HE HAS BLURRY VISION, FEELING FATIGUE, SHAKY. CUSTOMER IS CONCERNED WITH RESULTS BEING HIGHER THAN HIS EXPECTED RANGE. CUSTOMER STATES THAT TWO WEEKS AGO, THE METER WAS READING OVER 200MG/DL. CUSTOMER CALLED THE DOCTOR OFFICE AND TOLD THEM ABOUT IT. THEY SCHEDULED FOR HIM TO GO DO SOME LABS, WHICH HE STATES HE DID DAYS AFTER. AFTER THE DOCTORS RECEIVE

  Patient problems: Blurred Vision; Fatigue; Shaking/Tremors

  MAUDE report 7924192 ↗
• MalfunctionAug 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 130-150MG/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 BEDROOM. DURING THE CALL ON (B)(6) 2019, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 160 AND 170MG/DL USING TRUE METRIX AIR METER. 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: (DATE/TIME NOT STORED CORRECTLY) (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7790161 ↗
• MalfunctionApr 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 213, 175, 142, 147 AND 159 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 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 10/27/2018 AND OPEN VIAL DATE IS FOUR DAYS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:213MG/DL DATE: (B)(6) 2018 TIME:11:15PM FASTING; RESULT 2:175MG/DL DATE: (B)(6) 2018 TIME:7:55PM FASTING; RESULT 3:142MG/DL DATE: (B)(6) 2018 TIME:9:54AM FASTING; RESULT 4:147MG/DL DATE: (B)(6) 2018 TIME:1:38PM FASTING; RESULT 5:159MG/DL DATE: (B)(6) 2019 TIME:8:38PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7459236 ↗
• MalfunctionApr 24, 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 170MG/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 OF SOMETIMES IN THE LOCKER AT WORK. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/27/2019 AND OPEN VIAL DATE IS 4 DAYS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY). REVIEW METERS MEMORY: (B)(6). CUSTOMER STATES HE TAKES HIS INSULIN AROUND 11PM EVERY NIGHT AND 289MG/DL AND 241MG/DL SHOULD HAVE BEEN LOWER DUE TO HIM TAKING HIS INSULIN. CUSTOMER STATES HE ATE A LITTLE EXTRA THAT NIGHT AS WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7454881 ↗
• MalfunctionApr 3, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-0 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 SYMPTOM OF SWOLLEN FACE. MEDICAL ATTENTION IS REPORTED AS A RESULT OF REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/27/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. METER READS E-0 ONCE THE BLOOD IS ABSORBED. NURSE STATES THE CUSTOMER HAS SWELLING ON THE RIGHT SIDE OF THE FACE IS GOING TO SEND THE CUSTOMER TO THE HOSPITAL. NURSE DOES NOT KNOW IF IT IS DUE TO DIABETES. NURSE CANNOT TROUBLESHOOT AT THIS TIME.

  Patient problems: Swelling

  MAUDE report 7392532 ↗
• MalfunctionMar 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR NO KNOWN DEVICE PROBLEM. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED BEING INACCURATE. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 146MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF BEING UNCONSCIOUS ON A PREVIOUS EVENT. CUSTOMER HAD NO SYMPTOMS AT THE TIME OF THE CALL. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE PREVIOUS 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 10/18/2017 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :233MG/DL DATE:(B)(6) 2018 TIME:04:30PM NON-FASTING, RESULT 2 :203MG/DL DATE:(B)(6) 2018 TIME:01:13PM NON-FASTING, RESULT 3 :384MG/DL DATE:(B)(6) 2018 TIME:12:13PM FASTING, RESULT 4 :283MG/DL DATE:(B)(6) 2018 TIME:09:07AM FASTING, RESULT 5 :306MG/DL DATE:(B)(6) 2018 TIME:05:41AM FASTING. CUSTOMER IS NOT CONCERNED WITH THESE RESULTS BECAUSE HER INSULIN PUMP IS BROKEN. CUSTOMER IS NOT HAPPY WITH THIS METER AT ALL BECAUSE SHE FEELS IT IS JUST INACCURATE. CUSTOMER CALLED SAYING HER BLOOD SUGAR IS NOT BEING READ ACCURATELY ON THIS METER. CUSTOM

  Patient problems: Loss of consciousness

  MAUDE report 7344824 ↗
• MalfunctionMar 13, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TESTS OF 585 AND 413 MG/DL. CUSTOMER STATED SHE IS UNSURE OF WHAT HER EXPECTED GLUCOSE TEST RESULT RANGE SHOULD BE. CUSTOMER IS NOT CONCERNED RESULTS ARE HIGH, ONLY THAT THEY ARE ERRATIC. CUSTOMER ONLY STARTED TO USE THE TRUEMETRIX AIR METER ON (B)(6) 2018. CUSTOMER STATED SHE HAD NOT BEEN TESTING AND HAD NOT BEEN ABLE TO CONTROL HER DIABETES. CUSTOMER STATED SHE HAD GONE TO THE DOCTOR ON (B)(6) 2018 FOR HER REGULAR BLOOD TEST AND WAS TOLD HER BLOOD GLUCOSE WAS HIGH. CUSTOMER DID NOT REMEMBER WHAT THE RESULTS WERE WHEN AT THE DOCTOR. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED HAVING A HEADACHE; 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 544 MG/DL 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 05/31/2019 AND OPEN VIAL DATE IS 02/17/2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HIST

  Patient problems: Headache

  MAUDE report 7336116 ↗
• MalfunctionMar 6, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. SCHOOL HEALTH AIDE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH ALL RESULTS OBTAINED AND HI. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-100MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF 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 THEIR POSSESSION TO SCHOOL. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED 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 UNKNOWN. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1:HIMG/DL TIME:7:59A DATE:2/09 FASTING, RESULT 2:503MG/DL TIME:12:23P DATE:2/08 FASTING, RESULT 3:489MG/DL TIME:5:48P DATE:2/07 FASTING, RESULT 4:178MG/DL DATE:1:31P DATE:2/07 FASTING, RESULT 5:155MG/DL TIME:12:07P DATE:2/07 FASTING, SCHOOL CALLING IN FOR THE CUSTOMER (B)(6). CALLER STATED THAT SHE TESTED FASTING AND RESULT DISPLAYED E5 AFTER

  Patient problems: Polydipsia

  MAUDE report 7318661 ↗
• MalfunctionFeb 20, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. SON IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 95 MG/DL. CUSTOMER STATED THEY HAD FELT SICK AND FELT LIKE THEIR BLOOD SUGAR SHOULD HAVE BEEN LOWER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 110 MG/DL. DURING THE CALL ON (B)(6) 2018 THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (B)(6) 2018 AS A RESULT OF THE METER'S READINGS. CUSTOMER STATED RESULTS OBTAINED USING TRUEMETRIX AIR METER WERE HIGHER THAN ANOTHER DEVICE; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. 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 (B)(6) 2018 AND OPEN VIAL DATE AT TIME OF CALL WAS TWO WEEKS. CUSTOMER STATED RESULTS OBTAINED (B)(6) 2018 WERE OBTAINED USING A DIFFERENT VIAL OF TEST STRIPS WITH THE SAME LOT NUMBER THAT HAD BEEN STORED CORRECTLY; CUSTOMER WAS NOT CONCERNED WITH THOSE RESULTS STATIN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7284176 ↗
• MalfunctionFeb 14, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-0 BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING LETHARGIC AND DRAINED. 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 DINING ROOM. 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 8/31/2018 AND OPEN VIAL DATE IS A WEEK AGO. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Lethargy

  MAUDE report 7270374 ↗
• MalfunctionFeb 5, 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 280 MG/DL (FASTING); THE CUSTOMER DID NOT REMEMBER WHEN THIS RESULT WAS TAKEN AND DID NOT SEE IT IN THE METER MEMORY. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 120 MG/DL. CUSTOMER IS PREGNANT. 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 ALSO STATED THAT SHE IS COMPARING THE RESULTS OF THE TRUEMETRIX AIR METER AGAINST ANOTHER HANDHELD METER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. 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 BEING STORED IN CUSTOMER'S PURSE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/16/2019 AND OPEN VIAL DATE IS DECEMBER 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER IS NOT CONCERNED WITH THE RESULTS OF 77 OR 85 MG/DL): (B)(6). THE CUSTOMER IS CONCERNED WITH THIS RESULT: THE CUSTOMER IS CONCERNED WITH A RESULT OF 280 MG/DL (FASTIN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7241024 ↗
• MalfunctionJan 19, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT OF E-0 ERROR: INVALID HEMATOCRIT. THE ERROR OCCURRED WITH MULTIPLE STRIPS. 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. CUSTOMER WAS UNABLE TO TROUBLESHOOT AT TIME OF INITIAL CALL AND STATED HE WOULD CALL BACK. CUSTOMER FOLLOWED UP ON THAT SAME DAY AND BLOOD TEST WAS PERFORMED AND PRODUCED RESULT OF E-0. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/24/2018 AND OPEN VIAL DATE AT TIME OF INITIAL CALL IS TWO WEEKS. ADVERSE EVENT NOT REPORTED AT TIME OF CALL ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7205984 ↗
• MalfunctionJan 12, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR 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. CUSTOMER STATED SHE HAD NOT TAKEN HER MEDICATION BECAUSE SHE HAD NOT BEEN ABLE TO TEST. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 57MG/DL USING TRUEMETRIX AIR METER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING WEAK AND TIRED; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/22/2019 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Fatigue; Weakness

  MAUDE report 7186100 ↗
• MalfunctionDec 29, 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 303 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 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 PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 135 MG/DL AND 161 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 11/17/2018 AND OPEN VIAL DATE IS 10/01/2017. 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 7155376 ↗
• MalfunctionNov 15, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-0 BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO160MG/DL. THE CUSTOMER FEELS WELL AT THE TIME OF THE CALL BUT DID REPORT SYMPTOMS ON (B)(6) 2017. MEDICAL ATTENTION IS REPORTED ON (B)(6) 2017 AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE OFFICE. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF E-0 AND E-0L USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/30/2018 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: 140 MG/DL DATE: (B)(6) 2017 TIME: 11:09PM FASTING, RESULT 2: 108 MG/DL DATE: (B)(6) 2017 TIME: 05:34M FASTING, RESULT 3: 120 MG/DL DATE: (B)(6) 2017 TIME: 02:01PM FASTING, RESULT 4: 136 MG/DL DATE: (B)(6) 2017 TIME: 09:27PM FASTING, RESULT 5: 111 MG/DL DATE: (B)(6) 2017 TIME: 03:18PM FASTING. CUSTOMER CONCERNED WITH HIS METER NOT READING BECAUSE HE CHECKS HIS BLOOD SUGAR 6 TIMES A DAY AND IS ON INS

  Patient problems: Blurred Vision; Lethargy

  MAUDE report 7033292 ↗
• MalfunctionNov 10, 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 229 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 PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 170 MG/DL AND 165 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 IS 10/31/2018 AND OPEN VIAL DATE AT TIME OF CALL IS FOUR WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 : 192 MG/DL DATE:(B)(6) 2017 TIME: 11:34 AM FASTING, RESULT 2 : 210 MG/DL DATE: (B)(6) 2017 TIME: 10:56 AM FASTING, RESULT 3 : 208 MG/DL DATE: (B)(6) 2017 TIME: 8:46 AM NON-FASTING, RESULT 4 : 175 MG/DL DATE: (B)(6) 2017 TIME: 3:50 PM NON-FASTING, RESULT 5 : 229 MG/DL DATE: (B)(6) 2017 TIME: 11:30 AM FASTING. CUSTOMER STATES HIGH BLOOD RESULTS. CUSTOMER FEELS WELL AND DOES NOT NEED MEDICAL ATT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7021858 ↗
• MalfunctionNov 3, 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 308, 282 AND 206 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130 - 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. CUSTOMER STATED THAT SHE IS USING ALCOHOL PADS TO CLEANSE FINGER BEFORE TESTING; CUSTOMER WAS ADVISED OF PROPER TESTING TECHNIQUE. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/24/2018 AND OPEN VIAL DATE IS (B)(6) 2017. CUSTOMER HAD ANOTHER UNOPENED BOTTLE OF TEST STRIPS WITH A DIFFERENT LOT NUMBER. BACK TO BACK BLOOD TEST DURING THE CALL ON (B)(6) 2017 WAS PERFORMED NON-FASTING USING THIS DIFFERENT LOT NUMBER OF TEST STRIPS AND PRODUCED TEST RESULTS OF 224 MG/DL AND 202 MG/DL USING TRUEMETRIX AIR METER. LOT NUMBER WAS NOT PROVIDED AT TIME OF CALL, ATTEMPTED TO CONTACT CUSTOMER TO OBTAIN AND VOICEMAIL WAS LEFT. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 : 308 MG/DL DATE: (B)(6) TIME: 10

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6999753 ↗
• MalfunctionNov 2, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. CUSTOMER WAS TRANSFERRED FROM CUSTOMER CARE COORDINATOR WHO STATED THAT CUSTOMER BELIEVES RESULTS FROM METER ARE NOT ACCURATE AND THAT CUSTOMER SAYS THAT SHE IS NOT FEELING WELL. CUSTOMER CAME ON THE LINE AND STATED THAT SHE HAD TO HANG UP BECAUSE SHE IS NOT FEELING WELL. CUSTOMER WAS ADVISED TO HANG UP AND CALL FOR MEDICAL ASSISTANCE. CUSTOMER THEN DISCONNECTED THE CALL; NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: No Information

  MAUDE report 6997577 ↗
• MalfunctionOct 17, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 216 AND 111 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 72 - 93 MG/DL. THE CUSTOMER'S MAIN CONCERN IS DUE TO THE METER READING ERRATIC, NOT HIGH RESULTS. 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 05/22/2018 AND OPEN VIAL DATE IS 07/27/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: 111MG/DL AND 216MG/DL BACK TO BACK FASTING. CUSTOMER CALLED IN STATES THE METER IS READING ERRATIC. CUSTOMER STATES HER METER READ 111MG/DL AND 216MG/DL BACK TO BACK FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6956287 ↗
• MalfunctionSep 19, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH THE RESULT OF 291 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 130 MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION. 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 222 AND 206 MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/15/2018 AND OPEN VIAL DATE IS WITHIN THE MONTH OF (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (DATE/TIME NOT STORED CORRECTLY) (B)(6). CUSTOMER CALLED IN STATING THE METER IS READING ERRATIC. CUSTOMER STATES THAT SHE WAS CONCERNED WHEN SHE OBTAINED A RESULT OF 291 MG/DL SHE WAS CONCERNED THAT THE RESULTS WERE HIGH, CUSTOMER TESTED AGAIN ON A DIFFERENT FINGER AND THE RESULTS WAS 160 MG/DL. CUSTOMER IS NOW CONCERNED THAT THE METER IS ERRATIC. CUSTOMER IS MORE CONCERNED THAT THE METER IS READING ERRATIC THAN HIGH. NON-FASTING RANGE IS 150-160 MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6875420 ↗
• MalfunctionAug 2, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR: TEST STRIP ERROR. THE E-5 ERROR OCCURRED AFTER THE SAMPLE HAS BEEN APPLIED. GRANDMOTHER IS CALLING ON BEHALF OF THE CUSTOMER, HER (B)(6) GRANDSON. GRANDMOTHER STATED SHE HAD TRIED TO PERFORM A BLOOD TEST ON THE CUSTOMER AND HAD GOTTEN THE E-5 ERROR FIVE TIMES. GRANDMOTHER STATED SHE WAS ABLE TO PERFORM A BLOOD TEST ON HER OTHER GRANDSON AND HAD OBTAINED A RESULT. AT THE TIME OF THE CALL ON (B)(6) 2017, GRANDMOTHER STATED CUSTOMER LOOKED SLEEPY BUT THAT IT WAS HIS NAP TIME. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. 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 04/30/2018 AND OPEN VIAL DATE WAS UNDISCLOSED. CUSTOMER ONLY HAD ONE VIAL OF TEST STRIPS. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Lethargy

  MAUDE report 6760291 ↗
• MalfunctionJul 11, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 164, 214 AND 130 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 - 119 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 08/31/2017 AND OPEN VIAL DATE IS MONTH OF (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 111MG/DL (B)(6) 2017 06:18 PM FASTING:YES; 164MG/DL (B)(6) 2017 07:00 PM FASTING:YES; 214MG/DL (B)(6) 2017 07:30 PM FASTING:YES; 89MG/DL (B)(6) 2017 06:30 PM FASTING:YES; 130MG/DL (B)(6) 2017 07:29 PM FASTING:YES. MEMORY CONCERNS: CUSTOMER IS CONCERNED WITH THE RESULTS OF 164, 214 AND 130MG/DL IN THE METER'S MEMORY. THE CUSTOMER WIFE CALLING SAYING THE CUSTOMER IS GETTING ERRATIC RESULTS. UNABLE TO CONFIRM. WHILE SPEAKING TO THERE WAS A CONCERN FOR HIGH R

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6701408 ↗