TRUE METRIX AIR TRUE METRIX AIR self monitoring blood glucose meter (REF REA4001-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00311917173894), received between Dec 1, 2016 and Jan 24, 2019 — classified as 65 malfunctions.

The most frequently reported specific device problem is “High Test Results” (45 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 6, 2026Class IOpen, Classified

   The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.

   Z-1547-2026 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2019High Test Results; Low Test Results; High Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND LOW BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH HIGH TESTS RESULTS FROM RESULTS OBTAINED OF294 AND 236MG/DL AND LOW RESULTS OBTAINED OF 89MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 180MG/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 ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2019, A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 245 AND 281MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/24/2020, 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 8274110 ↗
• MalfunctionDec 27, 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 275, 269 AND 115 MG/DL. CUSTOMER ALSO STATED SHE HAD TESTED THAT MORNING AND OBTAINED A RESULT OF 200 MG/DL FASTING. CUSTOMER STATED THE HIGH READINGS STARTED THAT TUESDAY. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 - 98 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 02/24/2020 AND CUSTOMER STATED THE VIAL WAS OPENED RECENTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:275MG/DL 9:50AM (B)(6) FASTING; RESULT 2:269MG/DL 935AM (B)(6) FASTING; RESULT 3:115MG/DL 10:11AM (B)(6) FASTING; RESULT 4:88MG/DL 9:16AM (B)(6) FASTING; RESULT 5:90MG/DL 10:30AM (B)(6) FASTING. CUSTOMER STATE THAT METER ARE READING HIGHER THAN USUAL. CUSTOMER DOES NOT KNOW WHAT HER A1C IS CUSTOMER STATED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8200591 ↗
• MalfunctionNov 28, 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 DASHES DISPLAYED ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF EXCESSIVE THIRST, BLURRY VISION, FEELS TIRED, AND HAS FREQUENT URINATION. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE LOCATION. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 232 MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/29/2020 AND OPEN VIAL DATE IS UNKNOWN.THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER CALLED IN STATES THE METER ONLY DISPLAYS THREE DASHES ON THE SCREEN. ASKED CUSTOMER TO TURN THE METER ON AND STATES HE SEES THREE DASHES. WALKED CUSTOMER THROUGH A PROPER TESTING TECHNIQUE AND METER READ 232 MG/DL FASTING. CUSTOMER ALSO STATES HIS TONGUE IS WHITE. CUSTOMER WAS AT THE LOCAL (B)(6) AND ONLY SPOKE SPANISH. SPOKE WITH PHARMACIST AND INFORMED HER OF THE SYMPTOMS AND THE WHITE TONGUE AND THAT HE WAS

  Patient problems: Blurred Vision; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 8110848 ↗
• MalfunctionNov 19, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. CUSTOMER IS CONCERNED WITH ALL THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 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 BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 152MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/20/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY). (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8084740 ↗
• MalfunctionNov 15, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULT OBTAINED OF 44 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-140 MG/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) 2018, A BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 216 MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2019 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 8074505 ↗
• MalfunctionNov 5, 2018High Test Results; High Test Results

  CUSTOMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CARETAKER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 213 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 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. DURING THE CALL ON (B)(6) 2018, THE CUSTOMER DECLINED TO PERFORM BACK TO BACK BLOOD TEST DUE TO BEING IN THE CAR AND UNABLE TO WASH HANDS PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2019 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 8039589 ↗
• MalfunctionNov 2, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 34MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT NOT FEELING WELL AT TIME OF INCIDENT. 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 KITCHEN. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS 196MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2019.L THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER'S MOTHER STATED THAT WHEN HER SON WAS HOME, HE TOOK HIS BLOOD GLUCOSE ON THE METER AND IT READ 34 MG/DL FASTING. MOTHER STATED THAT SON DRANK SOME SODA AND TOOK HIS BLOOD AGAIN AND GOT A RESULT OF 210 MG/DL NON- FASTING. CUSTOMERS MOTHER STATED THAT SON WAS NOT FEELING WELL LATER THAT DAY AND SHE TOOK HIM TO THE HOSPITAL. WHEN CUSTOMER ARRIVED AT THE HOSPITAL, BLOOD SUGAR WAS 200 PLUS NON-FASTING (NOT SURE OF WHAT THE ACTUAL

  Patient problems: No Information

  MAUDE report 8034616 ↗
• MalfunctionOct 8, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 75, 79. 64 AND 66MG/DL. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-100MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF LOW BLOOD SUGAR (NOT SPECIFIED) ON PREVIOUS EVENTS. CUSTOMER FELT WELL AT THE TIME OF THE CALL. MEDICAL ATTENTION 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 BY CUSTOMER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/16/2019 AND OPEN VIAL DATE IS ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY:(TIME AND DATE IS NOT CORRECT IN THE METER) (B)(6). CUSTOMER STATED THAT WHEN SHE IS GETTING LOW RESULT SHE FEELS SYMPTOMS OF LOW. CUSTOMER HAS GONE TO THE DOCTOR'S OFFICE SEVERAL TIMES AND COMPARED METER TO METER AND WITH OUR METER, THE READINGS WERE 70 AND BELOW AND WITH THEIR METER READING WERE IN THE 80-90MG/DL WITHIN 5 TO 10 MINS. CUSTOMER ALSO WENT TO THE HOSPITAL DUE TO OUR METER. CUSTOMER WAS HAVING SYMPTOMS OF LOW AND TESTED WITH OUR METER RES

  Patient problems: Hypoglycemia

  MAUDE report 7942797 ↗
• MalfunctionSep 24, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 90, 78, 101, 113 AND 129 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 200 MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING DIZZY AND SHAKY. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. DURING THE CALL ON (B)(6) 2018, 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 09/29/2019 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: Dizziness; Shaking/Tremors

  MAUDE report 7903511 ↗
• MalfunctionAug 16, 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-2 ERROR CODE. THE E-2 ERROR OCCURRED AFTER THE BLOOD SAMPLE WAS ABSORBED. CUSTOMER WAS USING THE CORRECT TEST STRIPS AND PRODUCT IS STORED ACCORDING TO SPECIFICATION. CUSTOMER JUST GOT THE TRUEMETRIX METER (B)(6) 2018. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 269 MG/DL USING TRUEMETRIX AIR METER. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. AT THE TIME OF THE CALL THE CUSTOMER REPORTED SYMPTOMS OF FEELING TIRED AND LETHARGIC AND PRESSURE IN THE EYES. CUSTOMER DID NOT NEED MEDICAL ATTENTION AT THE TIME OF THE CALL. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2019 AND OPEN VIAL DATE IS UNDISCLOSED.

  Patient problems: Fatigue; Lethargy

  MAUDE report 7789023 ↗
• MalfunctionJul 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 233 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 109 - 117 MG/DL. CUSTOMER ALSO STATED THAT THE RESULTS FROM THE TRUEMETRIX AIR METER WERE HIGHER THAN RESULTS FROM DOCTOR'S METER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. 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 233 MG/DL AND 256 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 07/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. CUSTOMER DECLINED TO REVIEW THE METER'S MEMORY FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7667224 ↗
• MalfunctionJun 28, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 179MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNKNOWN. THE CUSTOMER DID REPORT SYMPTOMS OF ANXIETY AND HEADACHE. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ANXIETY REPORTED SYMPTOMS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2018 BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY CUSTOMER STATES THAT ON (B)(6) 2018 GLUCOSE WAS READING HIGH GLUCOSE RESULTS OF 179 MG/DL, NOT SURE IF IT WAS FASTING OR NON, WITH TRUE METRIX METER. CUSTOMER CALLED THE AMBULANCE AND READING ON AMBULANCE WAS 118 MG/DL NOT FASTING; BOTH TESTS CONDUCTED WITHIN 10 MINUTES OF EACH OTHER. CUSTOMER WAS HAVING SYMPTOMS OF HYPERGLYCEMIC HEADACHE AND STRESS ANXIETY. CUSTOMER STATES WHILE AMBULANCE WAS THERE ON SHE CONSUMED FOOD BEFORE THE AMBULANCE ARRIVED SUCH AS PINEAPPLES AND ORANGES AND BECAUSE OF THIS, PER CUSTOMER, SHE DID NOT REQUIRE ANY TREATMENTS FROM THE

  Patient problems: Anxiety; Headache

  MAUDE report 7647605 ↗
• MalfunctionJun 19, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK TEST RESULTS OF 500 AND 401 MG/DL. DAUGHTER DID NOT KNOW THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE BUT STATED CUSTOMER RUNS FAIRLY HIGH. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER HAD SOUGHT MEDICAL ATTENTION DUE TO THE HIGH BLOOD GLUCOSE RESULTS OBTAINED. DAUGHTER STATED PRIOR TO CUSTOMER GOING TO THE HOSPITAL, HER BLOOD GLUCOSE TEST RESULTS WERE IN THE 400'S MG/DL AND WHEN AT THE HOSPITAL CUSTOMER'S BLOOD GLUCOSE TEST RESULTS WERE IN THE HIGH 400'S MG/DL AND 500 MG/DL. DAUGHTER DID NOT HAVE THE EXACT NUMBERS. THE CUSTOMER WAS ADMINISTERED INSULIN. DAUGHTER DID NOT KNOW THE HOSPITAL DIAGNOSIS. DAUGHTER DID NOT KNOW IF ANY NEW MEDICATIONS WERE SUGGESTED. DAUGHTER DID NOT PROVIDE DATE CUSTOMER HAD GONE TO HOSPITAL; DAUGHTER STATED CUSTOMER WAS DISCHARGED ON (B)(6) 2018. WHEN CUSTOMER LEFT THE HOSPITAL HER BLOOD GLUCOSE TEST RESULT WAS IN THE 190'S MG/DL. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE

  Patient problems: Hyperglycemia

  MAUDE report 7613777 ↗
• MalfunctionJun 13, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR TEST STRIP NOT RECOGNIZING OR TEST STRIP NOT ABSORBING THE BLOOD. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER STATED THAT ONCE THE TESTS STRIP IS INSERTED INTO THE TRUEMETRIX AIR METER AND THE BLOOD SAMPLE IS ABSORBED, THE METER DOES NOT GO INTO TEST MODE. THE CUSTOMER WAS USING THE PROPER STRIPS AND CORRECT TESTING TECHNIQUE. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. ON (B)(6) 2018, THE CUSTOMER HAD FELT DIZZY AND HAD BEEN TAKEN TO THE HOSPITAL. THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN AT THE HOSPITAL WAS 300 MG/DL NON-FASTING AND THE DIAGNOSIS WAS HYPERGLYCEMIA. THE CUSTOMER WAS TREATED WITH IV FLUIDS, NO INSULIN AND WAS DISCHARGED THE SAME DAY. CUSTOMER WAS NOT PRESCRIBED ANY NEW MEDICATIONS AND DID NOT HAVE ANY MEDICATION CHANGES. CUSTOMER WAS TOLD TO TEST EVERY DAY AND SHOW THE DOCTOR HIS RESULTS. ADDITIONAL BLOOD TEST PERFORMED USING THE TRUEMETRIX AIR METER RESULTED IN E-2 ERROR MESSAGE. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 130 MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01

  Patient problems: Dizziness

  MAUDE report 7595914 ↗
• MalfunctionMay 15, 2018High Test Results; Low Test Results; High Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO AND HIGH BLOOD GLUCOSE RESULTS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 140MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING SPACY, DIZZY, SHAKY, AND WEAK. (EALIER THIS WEEK). 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 PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 172 AND 176MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:57MG/DL DATE: (B)(6) 2018 TIME:3:48PM N/FASTING; RESULT 2:64MG/DL DATE: (B)(6) 2018 TIME:3:42PM N/FASTING; RESULT 3:302MG/DL DATE: (B)(6) 2018 TIME:10:57PM FASTING; RESULT 4:264MG/DL DATE: (B)(6) 2018 TIME:10:57PM FASTING; RESULT 5:65MG/DL DATE:(B)(6) 2018 TIME:7:00PM N/FASTING; RESULT 6:LO DATE: (B)(6) 2018 TIME: 6:59PM FASTING; CUSTOMER STATES HE HAS HAD HYPOGLYCEMIC EVENTS THIS WEEK DUE TO THE METER READINGS. PER HIS SLIDING SCALE

  Patient problems: Dizziness; Shaking/Tremors; Weakness

  MAUDE report 7514316 ↗
• MalfunctionMay 10, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. CUSTOMER WANTS TO KNOW WHAT THE HI MEANS. CUSTOMER STATED THAT HIS DOCTOR IS TRYING TO GET HIS BLOOD GLUCOSE BACK TO HIS EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE OF 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 NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/22/2019 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 7504385 ↗
• MalfunctionMay 2, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI DISPLAY. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 89-100MG/DL. THE CUSTOMER DID REPORT SYMPTOM OF PASSING EARLIER THIS YEAR. MEDICAL ATTENTION IS REPORTED AS A RESULT OF REPORTED SYMPTOMS.THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 3/31/2019 AND OPEN VIAL DATE IS A MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1:505MG/DL DATE: (B)(6) 2017 TIME:2:13PM NON- FASTING; RESULT 2:HI DISPLAY DATE: (B)(6) 2017 TIME:2:09PM NON- FASTING; RESULT 3:411MG/DL DATE: (B)(6) 2017 TIME:11:40PM NON- FASTING; RESULT 4:292MG/DL DATE:N/A TIME:12:01PM NON- FASTING; RESULT 5:471MG/DL DATE: (B)(6) 2017 TIME:10:14PM NON- FASTING. CUSTOMER IS NOT AWARE OF HER A1C AND SCHEDULED FOR FOLLOW UP NEXT MONTH. CUSTOMER HAS SOME CONFUSION ABOUT HER MEDICATIONS. CUSTOMER LIVES ALONE AND STATES SHE PASSES OUT EVERY 6 MONTHS. CUSTOMER STATES PASSED OUT AND WAS IN THE HOSPITAL (B)(6) 2017 UNTIL (B)(6) 2018 BUT DOES NOT RECALL THE REASON WHY. CUSTOMER IS STORING

  Patient problems: Fainting

  MAUDE report 7481550 ↗
• MalfunctionApr 19, 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 100 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 BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/22/2018 AND OPEN VIAL DATE IS UNKNOWN. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). CUSTOMER CALLED TO ERASE ALL HIS BLOOD RESULTS THEN HE WANTED TO CHANGE HIS TIME AND DATE WHICH WE DID. I DID TELL HIM WE COULD NOT ERASE THE BLOOD RESULTS. HE THEN PROCEEDED TELL ME THAT HIS RESULTS WERE HIGH FOR HIM. HE WENT TO THE DR (ROUTINE SCHEDULED APPOINTMENT) AND BROUGHT HIS METER. THE METER READ 179 MG/DL AND THE LAB RESULTS READ 159 MG/DL NON- FASTING. I DID TELL THE CUSTOMER THAT THE METER CAN BE A 15% VARIANCE AND HE STILL THINKS THAT THE METER IS READING TOO HIGH. HE IS STORING THE STRIPS IN THE BATHROOM. I TOLD HIM TO TAKE STRIPS OUT OF THE BATHROOM AND TO STORE THE STRIPS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7443052 ↗
• MalfunctionApr 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 458 MG/DL NON-FASTING. THE CUSTOMER'S EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 180 - 190 MG/DL; 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 PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 232 MG/DL AND 250 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 (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 7440879 ↗
• MalfunctionMar 16, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-2 ERROR: SAMPLE NOT DETECTED OR USING WRONG TEST STRIP. THE E-2 ERROR OCCURRED AFTER THE BLOOD SAMPLE WAS APPLIED. CUSTOMER WAS USING THE CORRECT TEST STRIPS. CUSTOMER HAD TWO DIFFERENT LOTS OF TEST STRIPS BUT BOTH LOTS WERE EXPIRED: MS1484, MANUFACTURER'S EXPIRATION DATE OF 06/19/2017 AND MS1332, MANUFACTURER'S EXPIRATION DATE OF 08/18/2016. CUSTOMER WAS ADVISED TO DISCARD EXPIRED PRODUCT. CUSTOMER WAS GOING TO PURCHASE NEW TEST STRIPS. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING TIRED AND BELIEVED IT TO BE DUE TO HER DIABETES. CUSTOMER DID NOT NEED MEDICAL ATTENTION AT THE TIME OF THE CALL. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER AS TEST STRIPS WERE EXPIRED. THE PRODUCT STORAGE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Fatigue

  MAUDE report 7345110 ↗
• MalfunctionMar 8, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOM OF HAVING DRY MOUTH AND INCREASED THIRST. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/15/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Polydipsia

  MAUDE report 7324091 ↗
• MalfunctionFeb 23, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT OF LOW BLOOD GLUCOSE RESUTS WITH SYMPTOMS. NURSE IS CALLING ON BEHALF OF THE CUSTOMER. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. NURSE STATED THAT CUSTOMER HAD BEEN HOSPITALIZED ON (B)(6) 2018. AT THAT TIME, THE CUSTOMER HAD SYMPTOMS OF GLAZED EYES AND SLURRED SPEECH. BLOOD GLUCOSE RESULTS OBTAINED USING THE TRUEMETRIX AIR METER WERE 20 AND 30 MG/DL. NURSE DID NOT DISCLOSE IF TESTS WERE PERFORMED FASTING OR NON-FASTING. NUSE REFUSED TO ANSWER FURTHER QUESTION AND DISCONNECTED CALL. FOLLOWED UP CALL WAS MADE AND AND VOICEMAIL WAS LEFT.

  Patient problems: No Code Available

  MAUDE report 7292799 ↗
• MalfunctionFeb 12, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-2 BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF E-2. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF DIZZY, HEADACHE, DRY MOUTH. 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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF E-2 USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Dizziness; Headache; Polydipsia

  MAUDE report 7263007 ↗
• MalfunctionJan 4, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-0: INVALID HEMATOCRIT. THE E-0 OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 421 MG/DL USING TRUEMETRIX AIR METER. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. AT THE TIME OF THE CALL THE CUSTOMER REPORTED SYMPTOMS OF DRY MOUTH, INCREASED THIRST AND INCREASED URINATION. CUSTOMER STATED HE WOULD SEEK MEDICAL INTERVENTION. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Code Available; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 7163828 ↗
• MalfunctionNov 29, 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 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. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON DATE, A BACK TO BACK BLOOD TEST WAS PERFORMED NONFASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 280 AND 323MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/15/1208 AND OPEN VIAL DATE IS ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1 :202 MG/DL DATE: (B)(6) TIME:10:06 AM FASTING. RESULT 2 :266 MG/DL DATE: (B)(6) TIME:10:20 PM FASTING. RESULT 3 :219 MG/DL DATE: (B)(6) TIME:12:18 PM FASTING. RESULT 4 :200 MG/DL DATE: (B)(6) TIME:10:08 PM FASTING. RESULT 5 :241 MG/DL DATE: (B)(6) TIME:10:43 PM FASTING. CUSTOMER STATES THAT WHEN TESTING, HIS RESULTS ARE HIGHER THAN NORMAL FASTING. NO CHANGES TO EXERCISE AND/OR DIET ROUTINE. DATE AND TIME NOT CURRENTLY SET U

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7067196 ↗