TRUE FOCUS TRUE FOCUS Self Monitoring Test Strip - 50ctRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00021292008956), received between Feb 3, 2020 and Oct 2, 2024 — classified as 7 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (23 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2024Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO. THE CUSTOMER STATED THAT SHE HAS NOT USED THE TRUE FOCUS METER SINCE MAY. THE CUSTOMER DOES NOT KNOW HER EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER REPORTED FEELING WEAK AND TIRED; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE CUSTOMER'S TEST STRIPS ARE EXPIRED: TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS (B)(6) 2023 AND OPEN VIAL DATE WAS NOT PROVIDED. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: LO DATE:(B)(6) 2024 TIME: 9:41 PM FASTING/NON-FASTING UNKNOWN. RESULT 2: LO DATE:(B)(6) 2024 TIME: 9:39 AM FASTING/NON-FASTING UNKNOWN. RESULT 3: 145 MG/DL DATE (B)(6) 2024 TIME: 8:37 PM FASTING/NON-FASTING UNKNOWN . RESULT 4: 132 MG/DL DATE: (B)(6) 2024 TIME: 8:04 PM FASTING. RESULT 5: 150 MG/DL DATE: (B)(6) 2024 TIME: 7:13 PM FASTING.

  Patient problems: Fatigue; Muscle Weakness/Atrophy; Nausea; Shaking/Tremors

  MAUDE report 20350331 ↗
• MalfunctionOct 1, 2024Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO; CUSTOMER WAS ALSO CONCERNED WITH RESULTS OBTAINED OF 182 AND 131 MG/DL. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. 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 PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE CUSTOMER'S TEST STRIPS ARE EXPIRED: CUSTOMER STATED HE DOES NOT TEST HIS BLOOD VERY FREQUENTLY AND NEVER REALIZED HIS STRIPS WERE EXPIRED. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/23/2022 AND OPEN VIAL DATE WAS NOT PROVIDED. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: LO DATE: ON (B)(6) TIME: 5:33AM FASTING, RESULT 2: LO DATE: ON (B)(6) TIME: 8:35AM FASTING, RESULT 3: 182 MG/DL DATE: ON (B)(6) TIME: 8:33AM FASTING, RESULT 4: LO DATE: ON (B)(6) TIME: 9:28AM FASTING, RESULT 5: 131 MG/

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346742 ↗
• MalfunctionJan 4, 2024Material Discolored; Material Discolored

  CONSUMER REPORTED COMPLAINT FOR PHYSICAL DEFECT OF TEST STRIPS. CUSTOMER STATED THAT THE TRUE FOCUS TEST STRIPS ARE BROWNISH IN COLOR WHERE THE SAMPLE SHOULD BE APPLIED. CUSTOMER ADVISED THAT SHE IS STORING THEM IN AN UNUSED BATHROOM AND THAT THE STRIPS HAVE BEEN OPENED FOR LONGER THAN 4 MONTHS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED. CUSTOMER WAS UPGRADED TO TRUE METRIX PRODUCT LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18449171 ↗
• MalfunctionJun 19, 2023Incorrect, 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 AND HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD GLUCOSE TEST RESULTS OF 217, 58 AND 200 MG/DL; CUSTOMER STATED THE TESTS HAD BEEN PERFORMED FASTING ON (B)(6)2023 AT AROUND 10:45 AM. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS < 155 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 NON-FASTING AND PRODUCED TEST RESULTS OF 204 MG/DL AND 224 MG/DL USING TRUE FOCUS METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/17/2024 AND TEST STRIPS WERE OPENED TWO WEEKS PRIOR TO CALL. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153370 ↗
• MalfunctionNov 4, 2022High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI; CUSTOMER HAD JUST EATEN 1 HOUR PRIOR TO TEST. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. AT THE TIME OF THE CALL THE CUSTOMER WAS FEELING DROWSY; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. DURING THE CALL, 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 06/28/2024 AND OPEN VIAL DATE IS (B)(6) 2022. MOTHER WAS UNABLE TO SEE THE SERIAL NUMBER ON THE METER. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Lethargy

  MAUDE report 15735207 ↗
• MalfunctionNov 3, 2022Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. WIFE STATED SHE HAD TRIED TO TEST HER BLOOD GLUCOSE USING HER HUSBAND'S METER. WIFE STATED THAT SHE TURNED THE TRUE FOCUS METER ON, INSERTED THE TEST STRIP WITH THE BLOOD ON IT AND SAW LO, AND THAT THE LO REMAINS ON THE SCREEN. CUSTOMER'S WIFE STATED THAT HER HUSBAND HAD OBTAINED LO RECENTLY. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS NOT DISCLOSED. 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 STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 08/24/2023 AND TEST STRIPS WERE OPENED A YEAR AGO (EXPIRED). PRODUCT STORAGE WAS NOT DISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15722161 ↗
• MalfunctionSep 13, 2022Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO. CUSTOMER STATED THAT HE HAS BEEN FASTING FOR 16 HOURS. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. 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 PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/30/2023 AND OPEN VIAL DATE IS (B)(6) 2022. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE NOT SET; CUSTOMER JUST GOT THE METER, ONLY 1 RESULT PROVIDED):RESULT 1: LO DATE:(B)(6) 2022 TIME: 6:01 AM FASTING (TEST TAKEN TODAY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411148 ↗
• MalfunctionAug 2, 2022Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110-114 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 NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE CUSTOMER'S OFFICE. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/30/2023 AND TEST STRIPS WERE OPENED THREE MONTHS PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET; ONLY ONE RESULT WAS PROVIDED AND CUSTOMER STATED THAT IT WAS OBTAINED ON (B)(6) 2022, EXACT TIME UNKNOWN): RESULT 1: LO DATE: (B)(6) TIME: 2:54 PM NON-FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15152634 ↗
• InjuryJun 23, 2022High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM METER TO METER COMPARISON TEST RESULTS OF 103MG/DL USING TRUE FOCUS METER, 83MG/DL USING PARAMEDICS METER AND 72MG/DL USING ANOTHER DEVICE. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-120MG/DL AND EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-200MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. HUSBAND STATED THAT ON (B)(6) 2022 CUSTOMER WAS UNCONSCIOUS AND EMT'S HAD BEEN CALLED. THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN CHECKED BY THE EMT'S HAD BEEN 39MG/DL NON-FASTING. THE EMT'S WERE ABLE TO RAISE CUSTOMER'S BLOOD GLUCOSE TO 83MG/DL; HUSBAND DID NOT DISCLOSE WHAT TREATMENT CUSTOMER HAD RECEIVED. THE METER TO METER COMPARISON TESTS WERE PERFORMED AT THIS TIME. THE DIAGNOSIS WAS HYPOGLYCEMIA. CUSTOMER DID NOT NEED TO GO TO THE HOSPITAL. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 202MG/DL USING TRUE FOCUS METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MA

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 14794886 ↗
• InjuryJun 17, 2022Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGES (E-2 AND E-5) AND LOW BLOOD GLUCOSE TEST RESULTS USING TWO TRUE FOCUS METERS; ADDITIONAL INTERNAL REPORT REFERENCE NUMBER (B)(4). CUSTOMER STATED SHE HAD PURCHASED BOTH METERS THE WEEK PRIOR TO THE CALL. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM METER TO METER COMPARISON RESULTS USING THE TRUE FOCUS METERS OF 63 AND 90 MG/DL AM FASTING. CUSTOMER DID NOT DISCLOSE WHICH TRUE FOCUS METER GAVE WHICH RESULT. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE 140- 150 MG/DL AM FASTING, 170- 200 MG/DL PM FASTING AND 320 MG/DL PM FASTING POST DINNER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION DUE TO THE BLOOD GLUCOSE TEST RESULTS OBTAINED WAS REPORTED AT THE TIME OF THE INITIAL CALL. DURING THE CALL, 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 03/20/2024 AND OPEN VIAL DATE IS (B)(6) 2022. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER HAS VISION ISSUE). CUSTOMER DECLINED A REPLACEMENT AND STATED THAT SHE WOULD CONTACT HER DOCT

  Patient problems: Hypoglycemia

  MAUDE report 14735764 ↗
• InjuryJun 17, 2022Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGES (E-2 AND E-5) AND LOW BLOOD GLUCOSE TEST RESULTS USING TWO TRUE FOCUS METERS; ADDITIONAL INTERNAL REPORT REFERENCE NUMBER (B)(4). CUSTOMER STATED SHE HAD PURCHASED BOTH METERS THE WEEK PRIOR TO THE CALL. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM METER TO METER COMPARISON RESULTS USING THE TRUE FOCUS METERS OF 63 AND 90 MG/DL AM FASTING. CUSTOMER DID NOT DISCLOSE WHICH TRUE FOCUS METER GAVE WHICH RESULT. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE 140- 150 MG/DL AM FASTING, 170- 200 MG/DL PM FASTING AND 320 MG/DL PM FASTING POST DINNER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION DUE TO THE BLOOD GLUCOSE TEST RESULTS OBTAINED WAS REPORTED AT THE TIME OF THE INITIAL CALL. DURING THE CALL, 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 03/20/2024 AND OPEN VIAL DATE IS (B)(6) 2022. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER HAS VISION ISSUE). CUSTOMER DECLINED A REPLACEMENT AND STATED THAT SHE WOULD CONTACT HER DOCT

  Patient problems: Hypoglycemia

  MAUDE report 14735502 ↗
• MalfunctionJun 1, 2022High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 511, 470, 337, 412 AND 331 MG/DL. THE CUSTOMER¿S EXPECTED 2 HOUR POST MEAL BLOOD GLUCOSE TEST RESULT RANGE IS 140-160 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 WAS NOT USING THE PROPER TESTING TECHNIQUE. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 317 MG/DL AND 388 MG/DL USING TRUE FOCUS METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE OFFICE. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/31/2023 AND OPEN VIAL DATE IS (B)(6) 2022. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: Hyperglycemia

  MAUDE report 14566090 ↗
• MalfunctionApr 14, 2022Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULT OBTAINED ON (B)(6) 2022 OF LO. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130-140 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, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER; WHEN THE CUSTOMER INSERTED THE TEST STRIP, THE LOW BATTERY SIGNAL DISPLAYED ON THE SCREEN AND THE TRUE FOCUS METER DID NOT GO INTO TEST MODE. THE BATTERY IN THE TRUE FOCUS METER HAD NEVER BEEN CHANGED, CUSTOMER HAS HAD THE TRUE FOCUS METER FOR LESS THAN ONE MONTH. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/13/2023 AND OPEN VIAL DATE IS (B)(6) 2022. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Hypoglycemia

  MAUDE report 14112752 ↗
• MalfunctionMar 16, 2022Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO. THE CUSTOMER¿S EXPECTED FASTING TWO HOURS POST MEAL BLOOD GLUCOSE TEST RESULT RANGE IS 99-120 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, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (BATHROOM). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/302023 AND OPEN VIAL DATE WAS NOT DISCLOSED. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: LO DATE: 2/12 TIME: 10:10 PM FASTING. RESULT 2: LO DATE: 2/12 TIME: 8:40 AM FASTING. RESULT 3: 119 MG/DL DATE: 2/11 TIME: 9:54 PM FASTING. RESULT 4: 101 MG/DL DATE: 2/09 TIME: 10:47 PM FASTING. RESULT 5: 97 MG/DL DATE: 2/08 TIME: 10:57 PM FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13789300 ↗
• MalfunctionFeb 7, 2022Incorrect, 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. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 20 AND 92 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 75-95 MG/DL AND EXPECTED PM NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 95-121 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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 96 MG/DL USING TRUE FOCUS METER; THE CUSTOMER WAS SATISFIED WITH THE RESULT OBTAINED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/19/2023 AND OPEN VIAL DATE IS (B)(6) 2022. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13470510 ↗
• MalfunctionJan 18, 2022High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 255, 152, 140, 128 AND 126 MG/DL. CUSTOMER WAS ALSO CONCERNED WITH FASTING METER TO LAB COMPARISON RESULTS OF 130 MG/DL USING TRUE FOCUS METER AND DOCTOR'S LAB TEST RESULT OF 82 MG/DL; THE METER TO LAB COMPARISON WAS PERFORMED DURING A SCHEDULED DOCTOR VISIT. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS BELOW 90 MG/DL AND EXPECTED PM NON-FASTING BLOOD GLUCOSE TEST RESULT IS BELOW 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, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 129 MG/DL USING TRUE FOCUS METER; CUSTOMER WAS SATISFIED WITH THE RESULT OBTAINED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/13/2023 AND TEST STRIPS WERE OPENED TWO WEEKS PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13280028 ↗
• MalfunctionJan 14, 2022Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 100MG/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 NOT PERFORMED BY THE CUSTOMER; CUSTOMER HAD DECLINED STATING HE HAD ATTEMPTED 5 TIMES THAT MORNING. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/31/2023 AND OPEN VIAL DATE IS (B)(6) 2021. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Hypoglycemia

  MAUDE report 13257577 ↗
• MalfunctionOct 11, 2021Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO. THE CUSTOMER DOES NOT KNOW HER EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUE. 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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 108MG/DL USING TRUE FOCUS METER; CUSTOMER WAS SATISFIED WITH THE RESULT OBTAINED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 08/24/2023 AND TEST STRIPS WERE OPENED ONE WEEK PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (ONLY ONE RESULT): RESULT 1 : LO DATE: 1/4 TIME: 2:29AM FASTING.

  Patient problems: Insufficient Information

  MAUDE report 12605408 ↗
• MalfunctionSep 13, 2021Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO. CUSTOMER STATED HE HAD PERFORMED A BACK TO BACK TEST AND OBTAINED LO AND 122MG/DL FASTING; CUSTOMER WAS NOT USING THE CORRECT TESTING TECHNIQUE. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 90MG/DL AND EXPECTED PM BLOOD GLUCOSE TEST RESULT IS 120MG/DL. CUSTOMER STATED HE ONLY TESTS THREE TIMES A WEEK. 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; CUSTOMER DID NOT HAVE ANY MORE TEST STRIPS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/31/2023 AND OPEN VIAL DATE IS TWO MONTHS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE NOT SET): (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 12463975 ↗
• MalfunctionSep 3, 2021Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO. CALLER STATED THE TRUE FOCUS HIS HER METER AND THAT HER FRIEND HAD USED IT AND HAD OBTAINED THE LO RESULT. THE EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS UNKNOWN. 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 PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/24/2022 AND TEST STRIPS WERE OPENED LAST YEAR (EXPIRED). THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: Hypoglycemia

  MAUDE report 12421537 ↗
• MalfunctionJul 23, 2021Image Display Error/Artifact; High Test Results; Image Display Error/Artifact; High Test Results

  CONSUMER INITIALLY REPORTED COMPLAINT FOR E-3 ERROR. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF HI USING TRUE FOCUS METER; THE CUSTOMER WAS NOT SATISFIED WITH THE RESULT OBTAINED. CUSTOMER STATED HE HAS OBTAINED HIGH BLOOD GLUCOSE TEST RESULTS USING THE TRUE FOCUS METER, THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 180MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT HE SPEAKS WITH HIS DOCTOR EVERYDAY DUE TO HIGH BLOOD GLUCOSE RESULTS; DOCTOR HAD INFORMED CUSTOMER HE IS FINE AND THAT THE TRUE FOCUS METER WAS NOT WORKING. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/31/2023 AND OPEN VIAL DATE IS (B)(6) 2021. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY; CUSTOMER STATED THAT THE METER DISPLAYED 3 ZEROS (000) AND DID NOT DISPLAY THE MEMORY.

  Patient problems: Insufficient Information

  MAUDE report 12218054 ↗
• MalfunctionJul 1, 2021Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. SON IS CALLING ON BEHALF OF THE CUSTOMER. 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 WAS NOT AVAILABLE AT THE TIME OF THE CALL; SON STATED HE WOULD CALL BACK. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12101771 ↗
• MalfunctionMay 3, 2021Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO AND HIGH BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO AND 300 MG/DL (FASTING/NON-FASTING STATUS IS UNKNOWN). THE CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUE (TESTING FROM SAME FINGER). THE CUSTOMER DOES NOT HAVE AN EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. 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; CUSTOMER WAS NOT AVAILABLE AT THE TIME. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING AREA. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/13/2022 AND OPEN VIAL DATE WAS NOT DISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 11760475 ↗
• InjuryApr 30, 2021Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-3). CUSTOMER'S TEST STRIPS ARE EXPIRED: THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/26/2020. CUSTOMER STATED HE HAD JUST PURCHASED THE TEST STRIPS THE DAY PRIOR TO THE CALL. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED HE HAD GONE TO THE HOSPITAL A FEW WEEKS PRIOR TO THE CALL; CUSTOMER DID NOT RECALL THE EXACT DATE. CUSTOMER STATED HE HAD PASSED OUT WHILE AT WORK AND HAD WOKEN UP IN THE HOSPITAL. CUSTOMER STATED HE HAD NOT TESTED WITH THE TRUEFOCUS METER THAT DAY. CUSTOMER STATED HIS BLOOD GLUCOSE TEST RESULT WHEN AT THE HOSPITAL HAD BEEN 749 MG/DL (FASTING/NON-FASTING STATUS WAS NOT DISCLOSED). CUSTOMER STATED HE WAS DIAGNOSED WITH HYPERGLYCEMIA AND WAS TREATED WITH TWO BAGS OF IV INSULIN. CUSTOMER STATED HE HAD BEEN HOSPITALIZED FOR THREE DAYS AND HAD BEEN PRESCRIBED INSULIN WHEN DISCHARGED.

  Patient problems: Hyperglycemia; Loss of consciousness

  MAUDE report 11752249 ↗
• MalfunctionMar 11, 2021Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO DISPLAY ON BLOOD GLUCOSE TEST. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 140MG/DL AND EXPECTED BEFORE DINNER FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-110 MG/DL. CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUE. CUSTOMER ONLY USED THE METER ONLY 3 TIMES 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 BLOOD TEST DURING THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/22/2022 AND TEST STRIPS WERE OPENED TWO DAYS PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER ONLY TESTED THREE TIMES): (B)(6).

  Patient problems: Hypoglycemia

  MAUDE report 11467114 ↗