TRUE FOCUS TRUE FOCUS Self Monitoring Blood Glucose MeterRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00311917188065), received between Jan 30, 2019 and Jan 11, 2024 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2024Failure to Power Up; Failure to Power Up

  CONSUMER REPORTED COMPLAINT FOR DEAD METER. CUSTOMER HAD PURCHASED THE TRUE FOCUS METER A MONTH AGO. THE TEST STRIPS ARE EXPIRED: MANUFACTURER¿S EXPIRATION DATE IS 09/30/2023 AND OPEN VIAL DATE WAS NOT DISCLOSED. CUSTOMER ALSO STATED THAT SHE COULD NOT FIND THE BATTERY FOR THE METER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT LAST NIGHT SHE DIDN'T EAT WELL; DUE TO THE CHEMOTHERAPY SHE HAD LOST HER APPETITE. CUSTOMER STATED THIS MORNING SHE WASN'T FEELING WELL, SHE WAS EXTREMELY HUNGRY, AND SHE HAD CALLED 911. THE PARAMEDICS HAD TESTED THE CUSTOMER'S BLOOD GLUCOSE AND OBTAINED RESULT OF 50 MG/DL FASTING. THE DIAGNOSIS WAS LOW BLOOD GLUCOSE AND CUSTOMER WAS GIVEN GLUCOSE TABLETS. CUSTOMER'S BLOOD GLUCOSE WAS TESTED AN HOUR LATER AND IT WAS 90 MG/DL NON FASTING. PARAMEDICS HAD INSERTED A NEW BATTERY IN THE TRUE FOCUS AND THE METER WASN'T COMING ON; CUSTOMER WAS ADVISED TO RETURN TO PHARMACY.

  Patient problems: Hypoglycemia; Increased Appetite

  MAUDE report 18495421 ↗
• InjuryMay 16, 2023Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-4). CUSTOMER STATED SHE HAD JUST PURCHASED THE METER THAT DAY. CUSTOMER WAS USING THE INCORRECT TEST STRIPS FOR THE METER; CUSTOMER WAS USING TRUE METRIX TEST STRIPS WITH THE TRUE FOCUS METER. CUSTOMER STATED SHE WOULD ATTEMPT TO GET REPLACEMENT FROM THE PHARMACY. THE CUSTOMER DID NOT FEEL WELL; CUSTOMER DID NOT PROVIDE ANY DETAILS REGARDING HER SYMPTOMS. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER DID NOT ADVISE SHE NOT BEEN FEELING WELL BEFORE SHE HAD PURCHASED THE METER.

  Patient problems: Insufficient Information

  MAUDE report 16938075 ↗
• InjurySep 14, 2021Battery Problem; Battery Problem

  CONSUMER REPORTED COMPLAINT FOR LOW BATTERY SYMBOL. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE BATTERY HAD NEVER BEEN CHANGED; CUSTOMER HAD JUST OBTAINED THE TRUE FOCUS METER. AT THE TIME OF THE CALL, THE CUSTOMER WAS FEELING LETHARGIC AND TIRED; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. THE CUSTOMER IS USING THE CORRECT BATTERY IN THE CORRECT ORIENTATION FOR THE METER. DURING TROUBLESHOOTING, DONE WITH THE CALLER, THE METER STILL SHOWS LOW BATTERY WHEN THE "S" BUTTON WAS PRESSED AND WHEN THE STRIP WAS INSERTED.

  Patient problems: Lethargy

  MAUDE report 12468582 ↗
• InjuryMar 18, 2021High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI AND HIGH BLOOD GLUCOSE TEST RESULTS. NIECE IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER HAD PURCHASED THE TRUE FOCUS METER THE DAY PRIOR TO CALL. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI AND 600 MG/DL. THE CUSTOMER DID NOT KNOW HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING DIZZY AND THAT HE MAY SEEK MEDICAL ATTENTION. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULT OF HI USING TRUE FOCUS METER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/22/2022 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST. RESULT HISTORY: (CUSTOMER UNABLE TO READ TIME AND DATE). RESULT 1: HI DATE: 2/19 TIME: 1:00 AM. RESULT 2: 600 MG/DL DATE/TIME: UNKNOWN NON-FASTING . RESULT 3: N/A. RESULT 4: N/A. RESULT 5: N/A.

  Patient problems: Dizziness

  MAUDE report 11517125 ↗
• MalfunctionDec 23, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. SISTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100MG/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 A BACK TO BACK BLOOD TEST WAS DECLINED. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/26/2020 AND OPEN VIAL DATE IS ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6). TIME AND DATE ON THE METER MEMORY ARE INCORRECT, ALL BLOOD RESULTS ARE DONE AS A FASTING IN THE MORNING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11070004 ↗
• InjuryOct 14, 2020Failure to Power Up; Failure to Power Up

  CONSUMER REPORTED COMPLAINT FOR LOW BATTERY SYMBOL. CUSTOMER STATED THE BATTERY HAD NOT BEEN CHANGED AND THAT SHE HAD ONLY BEEN USING THE TRUEFOCUS METER FOR TWO WEEKS. DURING THE CALL, THE TRUEFOCUS METER POWERED ON USING THE POWER BUTTON AND WHEN A TEST STRIP WAS INSERTED. THE LOW BATTERY SYMBOL WAS NOT ON. THE METER TURNED OFF WHEN THE POWER BUTTON WAS HELD. THE TRUEFOCUS METER DISPLAYED THE BLOOD DROP TO INDICATE IT WAS READY TO PERFORM A TEST. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING TIRED AND OFF BALANCE; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 119 MG/DL USING TRUEFOCUS METER; CUSTOMER WAS SATISFIED WITH THE RESULT OBTAINED.

  Patient problems: Fatigue

  MAUDE report 10680428 ↗
• MalfunctionAug 13, 2020Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO DISPLAY. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. SYMPTOMS OR MEDICAL ATTENTION WERE NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/13/2022 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10402274 ↗
• MalfunctionMay 26, 2020Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF LO. CUSTOMER JUST STARTED TO USE THE TRUEFOCUS METER ON DAY OF CALL. THE CUSTOMER DID NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER REPORTED FEELING DIZZY, NO MEDICAL ATTENTION WAS REQUIRED AT THE TIME OF THE CALL. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 135 MG/DL USING TRUEFOCUS METER; FIFTEEN MINUTES LATER CUSTOMER REPORTED FEELING FINE. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 08/29/2020 AND OPEN VIAL DATE IS (B)(6) 2020. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Dizziness

  MAUDE report 10089399 ↗
• MalfunctionAug 5, 2019Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF LO FASTING. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 100 MG/DL. CUSTOMER STATED THAT AFTER HE OBTAINED THE RESULT OF LO, HE PERFORMED A BLOOD USING ANOTHER DEVICE WITHIN TWO MINUTES AND OBTAINED A RESULT OF 105 MG/DL FASTING. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIPS ARE NEW FROM THE PHARMACY; TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/29/2020 AND OPEN VIAL DATE IS 07/11/2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8861674 ↗
• MalfunctionJun 14, 2019Unable to Obtain Readings; Low Test Results; Unable to Obtain Readings; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO DISPLAY. CUSTOMER STATES THAT HE RECENTLY GOT THE METER AND IS GETTING A LOT OF ERRORS. CUSTOMER HE RUN A BLOOD TEST AND GOT 103MG/DL 3 TIMES. CUSTOMER HAVE ONLY BEEN USING THE METER FOR 3-4 DAYS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNKNOWN. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/29/2020 AND OPEN VIAL DATE IS (B)(6) 2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8701886 ↗
• MalfunctionApr 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO DISPLAY, ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH ERRATIC TESTS RESULTS FROM RESULTS OBTAINED OF 42 AND 131MG/DL AND METER DISPLAY OF LO. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 78-130MG/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 OFFICE. DURING THE CALL A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/29/2020 AND OPEN VIAL DATE IS (B)(6) 2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. RESULT 1: 131MG/DL, DATE: (B)(6), TIME: 10:30PM FASTING, RESULT 2: 42MG/DL, DATE: (B)(6), TIME: 10:26PM FASTING, RESULT 3: 172MG/DL, DATE: (B)(6), TIME: 3:16AM UNKNOWN, RESULT 4: 128MG/DL, DATE: (B)(6), TIME: 6:56PM UNKNOWN, RESULT 5: LO, DATE: (B)(6), TIME: 6:54PM UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8556234 ↗
• MalfunctionApr 23, 2019Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO, HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF LO, 112, 165, 167 AND 151 MG/DL. CUSTOMER WAS ALSO COMPARING METER TO THREE OTHER METERS. ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. CUSTOMER STATED THAT HE WOULD NOT EAT FROM THE EVENING TO THE NEXT MORNING AND WOULD STILL GET RESULTS OVER 120 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 110 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 A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 146 MG/DL AND 135 MG/DL USING METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/29/2020 AND OPEN VIAL DATE IS 02/2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: LO 845 (B)(6) FASTING. RESULT 2: 112MG/DL (B)(6) 528P FASTING. RESULT 3: 165MG/DL 11:00 (B)(6) FASTING. RESULT 4: 167MG/DL 1058A (B)(6) FASTING. RESULT 5: 151 8:47A (B)(6) FASTI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8540586 ↗
• MalfunctionJan 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC/LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH LOW TESTS RESULT OF 20MG/DL, METER TO METER COMPARISON OF 20MG/SL USING THE TRUE FOCUS VS 100MG/DL USING THE COMPETITOR'S METER AND ERRATIC RESULTS OF 20MG/DL AND 200MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2019, A BLOOD TEST WAS NOT PERFORMED. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/29/2020 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CALLED CUSTOMER BACK PER REQUEST FROM CUSTOMER ON (B)(6) 2019. CUSTOMER USING THE TRUE FOCUS METER PURCHASE ON (B)(6) 2018 WITH TEST STRIPS REPORTED THAT SHE GOT 20MG/DL AND TESTES MINUTES LATER OF COMPETITOR'S METER AND GOT A RESULT OF 100MG/DL CUSTOMER STATED SHE THEN RETESTED ON THE TRUE FOCUS ON THE SAME FINGER AND GOT 200MG/DL. CUSTOMER STATED IT WAS MINUTES WITHIN EACH OTHER AND THAT SHE DID NOT EAT OR DRINK ANYTHING IN BETWEEN. CUSTOMER STATED THAT TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8290880 ↗