TRUE FOCUSRecalls & reported problems across all models

We found 2 models of TRUE FOCUS by Trividia Health, Inc. in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Jan 30, 2019 and Oct 2, 2024 — classified as 12 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (30 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported TRUE FOCUS problems

TRUE FOCUS models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TRUE FOCUS TRUE FOCUS Self Monitoring Test Strip - 50ct

  Glucose Dehydrogenase, Glucose
  35 reports
• TRUE FOCUS TRUE FOCUS Self Monitoring Blood Glucose Meter

  Single (Specified) Analyte Controls (Assayed And Unassayed)
  13 reports

Recent TRUE FOCUS adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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