TRUEtrack TRUEtrack 50 Blood Glucose Test StripsRecalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 00021292008642), received between Nov 18, 2016 and Aug 8, 2023 — classified as 13 injuries, 140 malfunctions.

The most frequently reported specific device problem is “High Test Results” (88 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 153 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  CONSUMER REPORTED COMPLAINT FOR PHYSICAL DEFECT OF TEST STRIPS. CUSTOMER STATED THAT WHEN HE HAD OPENED THE TEST STRIP VIAL THE TEST STRIPS HAD BEEN STUCK TOGETHER AND THAT HE HAD TO PULL THEM APART. CUSTOMER STATED THAT THE VIAL OF STRIPS WAS SEALED AND INTACT WHEN RECEIVED. 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 TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/15/2023 AND OPEN VIAL DATE WAS NOT DISCLOSED. CUSTOMER HAS DISCONTINUED PRODUCT (TRUETRACK) AND WAS UPGRADED TO TRUE METRIX PRODUCT LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17479123 ↗
• MalfunctionJun 26, 2023No Apparent Adverse Event; No Apparent Adverse Event

  CONSUMER CALLED TO INQUIRE ABOUT PRODUCT - DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER HAS DISCONTINUED PRODUCT - CUSTOMER HAS TRUE TRACK METER AND TEST STRIPS. THE TEST STRIPS ARE EXPIRED - MANUFACTURER'S EXPIRATION DATE IS 10/31/2017 AND TEST STRIPS ARE PART OF RECALL. CUSTOMER DID NOT REPORT A COMPLAINT ASSOCIATED WITH THE PRODUCTS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCTS WAS REPORTED. CUSTOMER HAS DIFFERENT BRAND METER AND TEST STRIPS SHE WILL BE USING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17204174 ↗
• MalfunctionApr 7, 2023High 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 315, 195, 164, 213 AND 250 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS <120 MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT IS <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. 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 02/22/2023 AND TEST STRIPS WERE OPENED 8 MONTHS PRIOR TO THE CALL. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. CUSTOMER WAS UPGRADED TO TRUE METRIX PRODUCT LINE. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY, CUSTOMER PROVIDED RESULTS FROM HER LOGBOOK: RESULT 1: 315 MG/DL DATE: (B)(6) AM FASTING. RESULT 2: 195 MG/DL UNKNOWN DATE AM FASTING. RESULT 3: 164 MG/DL UNKNOWN DATE PM FASTING. RESULT 4: 213 MG/DL UNKNOWN DATE AM FASTING. RESULT 5: 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16700341 ↗
• InjuryJan 5, 2023High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS USING DISCONTINUED PRODUCT - CUSTOMER HAS TRUE TRACK METER AND TEST STRIPS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIPS ARE EXPIRED - MANUFACTURER'S EXPIRATION DATE IS 04/30/2020. THE CUSTOMER DID NOT PROVIDE TEST RESULTS OF CONCERN, BUT STATED HE WAS CONCERNED WITH A HIGH RESULT OBTAINED AFTER HE HAD BEEN DISCHARGED FROM THE HOSPITAL. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. AT THE TIME OF THE CALL THE CUSTOMER REPORTED EXPERIENCING BLURRY VISION. CUSTOMER STATED THAT 10 DAYS PRIOR HE HAD GONE TO THE HOSPITAL. CUSTOMER STATED THAT HIS LEFT ARM AND LEG HAD BEEN PARALYZED AND THAT HE HAD FALLEN FROM HIS BED. CUSTOMER'S WIFE HAD TAKEN HIM TO A CLINIC WHO HAD ADVISED CUSTOMER TO GO TO THE ER, WHERE HE HAD A BLOOD TEST AND ECG, AS WELL AS OTHER TESTS. CUSTOMER HAD BEEN TOLD HIS BLOOD SUGAR WAS HIGH; CUSTOMER DOES NOT RECALL THE EXACT RESULT OBTAINED VIA A URINE TEST. CUSTOMER STATED HE HAD NOT BEEN GIVEN A DIAGNOSIS. CUSTOMER STATED THE DOCTOR HAD INFORMED HIM IT COULD HAVE BEEN A MILD STROKE OR TIA SINCE ONCE HAD ARRIVED AT THE ER HIS

  Patient problems: Blurred Vision; Fall; Paralysis

  MAUDE report 16102048 ↗
• MalfunctionJul 26, 2022High 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 222 AND 287 MG/DL; TESTS WERE PERFORMED BACK TO BACK AND CUSTOMER DID NOT USE THE PROPER BACK TO BACK TESTING TECHNIQUE. THE CUSTOMER¿S EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 108-125 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 12/22/2022 AND OPEN VIAL DATE IS UNKNOWN. 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: 222 MG/DL, DATE: (B)(6) 2022, TIME: 2:11 PM FASTING. RESULT 2: 287 MG/DL, DATE: (B)(6) 2022, TIME: 2:14 PM FASTING. RESULT 3: 125 MG/DL, DATE: (B)(6) 2022, TIME: 2:57 PM FASTING. RESULT 4: 165 MG/DL, DATE: (B)(6) 2022, TIME: 2:38 PM FASTING. RESULT 5: 116 MG/DL, DATE: (B)(6) 2022, TIME: 2:59 PM FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102559 ↗
• MalfunctionApr 4, 2022Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. GRANDDAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 64 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 125 MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 170-200 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 PM FASTING AND PRODUCED TEST RESULTS OF 234 MG/DL AND 271 MG/DL USING TRUE TRACK METER; THE CUSTOMER WAS NOT SATISFIED WITH THE RESULTS OBTAINED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/17/2022 AND TEST STRIPS WERE OPENED TWO DAYS PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE NOT SET): (B)(6).

  Patient problems: Hypoglycemia

  MAUDE report 13995047 ↗
• MalfunctionMar 22, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  CONSUMER REPORTED COMPLAINT FOR PHYSICAL DEFECT OF TEST STRIPS. CUSTOMER STATED THAT THE TEST STRIPS ARE STUCK TOGETHER. CUSTOMER STATED THAT SHE PURCHASED TWO VIALS OF TEST STRIPS ON (B)(6) 2022 (SAME LOT NUMBER); ONLY ONE OF THE VIALS HAS BEEN OPENED BY THE CUSTOMER. CUSTOMER STATED THAT THE TEST STRIPS THAT WERE STICKING DO NOT WORK. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/31/2023. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13847671 ↗
• MalfunctionMar 3, 2022Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 69, 76, 71 AND 78MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 120MG/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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 363MG/DL USING TRUE TRACK 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 07/31/2023 AND OPEN VIAL DATE IS ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 69MG/DL, DATE: (B)(6) 2022 ,TIME: 7:30 AM, FASTING; RESULT 2: 76MG/DL ,DATE: (B)(6) 2022, TIME: 7:45 AM ,FASTING ; RESULT 3: 71MG/DL ,DATE: (B)(6) 2022 ,TIME: 7:30 AM ,FASTING ; RESULT 4: 78MG/DL ,DATE: (B)(6) 2022 ,TIME: 7:45 AM ,FASTING; RESULT 5: 76MG/DL ,DATE: (B)(6) 2022 ,TIME: 7:30 AM ,FASTING.

  Patient problems: Hypoglycemia

  MAUDE report 13659681 ↗
• MalfunctionFeb 17, 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 BACK TO BACK BLOOD TESTS OF 260, 180 AND 290MG/DL AM FASTING. THE CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUE. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-110MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 170-180MG/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 BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/19/2023 AND OPEN VIAL DATE IS ONE WEEK PRIOR TO CALL. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13550459 ↗
• MalfunctionDec 28, 2021High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 494MG/DL. THE CUSTOMER¿S EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200-250MG/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 TECHNIQUES. 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 TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/22/2023 AND OPEN VIAL DATE IS ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE NOT SET): RESULT 1: 215 MG/DL DATE: (B)(6) 2021 TIME: 10:12PM FASTING, RESULT 2: 494 MG/DL DATE: (B)(6) 2021 TIME: 7:54PM FASTING, RESULT 3: 175 MG/DL DATE: (B)(6) 2021 TIME: 5:43PM FASTING, RESULT 4: 147 MG/DL DATE: (B)(6) 2021 TIME: 12:00PM FASTING, RESULT 5: 229 MG/DL DATE: (B)(6) 2021 TIME: 7:41AM FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13097577 ↗
• MalfunctionSep 20, 2021No Apparent Adverse Event; No Apparent Adverse Event

  (B)(6) HUSBAND IS CALLING ON BEHALF OF CUSTOMER TO GET ASSISTANCE WITH THE METER AND RUNNING A BLOOD TEST. CUSTOMER DID NOT ALLEGE A PRODUCT DEFECT. CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION WITH USE OF PRODUCT WAS NOT REPORTED. THE TEST STRIPS ARE EXPIRED: 07/31/2017. CUSTOMER TEST STRIPS HAVE BEEN AFFECTED BY THE RECALL. CUSTOMER WILL PURCHASE NEW STRIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12495372 ↗
• InjuryAug 31, 2021Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-3). DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. AT THE TIME OF THE CALL THE CUSTOMER REPORTED SYMPTOMS OF FREQUENT URINATION AND INCREASED THIRST; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. CUSTOMER STATED THAT ON (B)(6) 2021 SHE HAD SYMPTOMS OF BLURRY VISION, FREQUENT URINATION AND INCREASE THIRST, AND HAD GONE TO A LOCAL CLINIC. CUSTOMER STATED HER BLOOD GLUCOSE TEST RESULT HAD BEEN ABOUT 300 MG/DL BUT THAT SHE WAS NOT EXACTLY SURE. THE DIAGNOSIS WAS HYPERGLYCEMIA AND HYPERTENSION. CUSTOMER WAS PRESCRIBED GLIPIZIDE, METFORMIN AND ACTOSE. 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 TEST STRIP LOT MANUFACTURERS EXPIRATION DATE IS 01/31/2020 (EXPIRED); THE CODE CHIP ALSO DID NOT MATCH. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. WHAT IS THE CUSTOMER REQUESTING TRAINING ON OR ASSISTANCE WITH: E-3 ERROR. WHAT INFORMATION WAS PROVIDED/ OR WHAT WAS ASSISTANCE WAS PROVIDED TO CUSTOMER: THE CUSTOMER IS FEELING SICK, HAVING FREQUENT URINATION, INCREASE THIRST. CUSTOMER WAS FEELING

  Patient problems: High Blood Pressure/ Hypertension; Urinary Frequency / Polyuria

  MAUDE report 12392446 ↗
• MalfunctionAug 30, 2021High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI. 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'S TEST STRIPS ARE EXPIRED: MANUFACTURER¿S EXPIRATION DATE IS 05/21/2020. COORDINATOR HAD INITIALLY SPOKEN WITH CUSTOMER AND TRANSFERRED CUSTOMER'S INFORMATION TO TECHNICIAN. TECHNICIAN HAD ATTEMPTED TO CONTACT CUSTOMER VIA TELEPHONE TO PROVIDE FURTHER ASSISTANCE. CALL HAD BEEN DISCONNECTED AND NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 12384473 ↗
• MalfunctionAug 27, 2021High Test Results; Low Test Results; High Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 258, 173, 73, 182 AND 191MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-160MG/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 (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/22/2023 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: (B)(6).

  Patient problems: Hyperglycemia

  MAUDE report 12380732 ↗
• MalfunctionAug 27, 2021Failure to Power Up; Failure to Power Up

  CONSUMER REPORTED COMPLAINT FOR DEAD METER. CUSTOMER STATED THE BATTERY HAD BEEN CHANGED ON (B)(6) 2021. THE CUSTOMER IS USING THE CORRECT BATTERY IN THE CORRECT ORIENTATION FOR THE METER. DURING THE CALL, THE TRUE TRACK METER POWERED ON USING THE POWER BUTTON AND WHEN A TEST STRIP WAS INSERTED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE CUSTOMER'S TEST STRIPS ARE EXPIRED - THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/25/2017 AND TEST STRIPS ARE PART OF RECALL.

  Patient problems: Insufficient Information

  MAUDE report 12380077 ↗
• MalfunctionAug 17, 2021High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CAREGIVER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 229, 192 AND 256 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-130 MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150-160 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, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 345 MG/DL USING TRUE TRACK METER; CUSTOMER WAS NOT SATISFIED WITH THE RESULT OBTAINED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/30/2022 AND TEST STRIPS WERE OPENED 2-3 DAYS 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 12333407 ↗
• MalfunctionJul 12, 2021High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-105 MG/DL AND EXPECTED PM NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 145-160 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, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 110 MG/DL USING TRUE TRACK 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 04/30/2022 AND TEST STRIPS WERE OPENED ONE MONTH PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: Hyperglycemia

  MAUDE report 12150504 ↗
• MalfunctionJul 9, 2021High 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 182, 291, 194, 176, 244 AND 220MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 112-202MG/DL, EXPECTED PRE-LUNCH FASTING BLOOD GLUCOSE TEST RESULT IS LESS THAN 120 MG/DL AND EXPECTED PRE-DINNER FASTING BLOOD GLUCOSE TEST RESULT IS 130MG/DL. THE 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 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 03/30/2023 AND OPEN VIAL DATE IS 3-4 WEEKS PRIOR TO CALL. 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 (DATE/TIME NOT SET): (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12146140 ↗
• InjuryJun 25, 2021High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. WIFE STATED THE TRUE TRACK IS HER METER BUT THAT HER HUSBAND WAS USING IT AND HAD OBTAINED THE HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 529, 429 AND 585 MG/DL. WIFE DID NOT KNOW CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. WIFE STATED THAT AT 5:30 AM ON (B)(6) 2021, CUSTOMER HAD PERFORMED A BLOOD TEST AND OBTAINED A RESULT OF 429 MG/DL FASTING AND HAD ADMINISTERED HUMALOG. AT 8:39 AM, CUSTOMER HAD TESTED AGAIN AND OBTAINED A RESULT OF 529 MG/DL NON-FASTING AND HAD CALLED THE AMBULANCE. HE WAS NOT EXPERIENCING ANY SYMPTOMS AT THE TIME, BUT HAD BEEN CONCERNED WITH THE RESULT. THE AMBULANCE HAD ARRIVED 20 MINUTES LATER AND PERFORMED A BLOOD TEST, AND CUSTOMER'S BLOOD GLUCOSE TEST RESULT WAS 270 MG/DL NON-FASTING. THEY INFORMED CUSTOMER THAT THE HUMALOG HE HAD ADMINISTERED WAS WORKING AND HIS BLOOD GLUCOSE WAS FINE. NO MEDICAL TREATMENT WAS PROVIDED AND CUSTOMER WAS NOT TAKEN TO THE HOSPITAL. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY

  Patient problems: Hyperglycemia

  MAUDE report 12068376 ↗
• MalfunctionMay 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TEST RESULTS OF 308, 108 AND 94 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 99 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 81 MG/DL AND 96 MG/DL USING TRUE TRACK METER; CUSTOMER WAS SATISFIED WITH THE RESULTS OBTAINED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/13/2023 AND OPEN VIAL DATE IS (B)(6) 2021. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE NOT SET): (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11903566 ↗
• MalfunctionMay 12, 2021High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER HAD ONLY PERFORMED ONE BLOOD TEST USING THE TRUE TRACK METER, OBTAINED HI AND IS CONCERNED WITH THE RESULT. DAUGHTER STATED A BLOOD TEST WAS PERFORMED USING ANOTHER DEVICE (SAME HAND/FINGER) AND CUSTOMER HAD OBTAINED A RESULT OF 338 MG/DL (FASTING/NON-FASTING STATUS UNKNOWN). THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS BELOW 200 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 BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/31/2021 AND OPEN VIAL DATE IS (B)(6) 2021. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: HI DATE: 4/13 TIME: 10:38P UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813700 ↗
• MalfunctionApr 14, 2021High 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 TEST RESULTS FROM RESULTS OBTAINED OF 452, 381, 340 AND 447 MG/DL. CUSTOMER WAS ALSO COMPARING RESULTS OBTAINED USING THE TRUETRACK METER TO ANOTHER DEVICE, AND STATED THE TRUETRACK RESULTS WERE HIGHER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS LESS THAN 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. 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 12/22/2022 AND THE TEST STRIPS WERE OPENED A FEW DAYS 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 11666882 ↗
• MalfunctionMar 31, 2021High 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 338, 370 AND 373 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 150 MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT IS 160 MG/DL. CUSTOMER ALSO STATED HE HAD PERFORMED CONTROL TESTS PRIOR TO CALL AND THE RESULTS HAD NOT BEEN WITHIN THE ACCEPTABLE RANGE (HIGH). 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 209 MG/DL AND 214 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/31/2022 AND TEST STRIPS WERE OPENED ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11597097 ↗
• MalfunctionMar 18, 2021Output Problem; Output Problem

  CONSUMER REPORTED COMPLAINT FOR TEST STRIP NOT ABSORBING THE BLOOD. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED. CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUE (ALCHOLOL). THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURERS EXPIRATION DATE IS 09/30/2021 AND OPEN VIAL DATE IS A FEW WEEKS PRIOR TO CALL. DURING THE CALL, A BLOOD TEST WAS ATTEMPTED TO BE PERFORMED BY THE CUSTOMER AND THE TEST STRIP DID NOT ABSORB THE BLOOD.

  Patient problems: Insufficient Information

  MAUDE report 11517775 ↗
• MalfunctionFeb 7, 2021High 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. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 250 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 (STORED IN THE KITCHEN). CUSTOMER'S TEST STRIPS WERE OPENED MORE THAN FOUR MONTHS AGO (EXPIRED). THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290622 ↗