TRUEplus TRUEplus Ketone Test StripsRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00021292008178), received between Nov 4, 2019 and Nov 8, 2022 — classified as 1 injury, 32 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2022Unsealed Device Packaging; Unsealed Device Packaging

  CONSUMER REPORTED COMPLAINT FOR OPEN VIAL. CUSTOMER STATED THAT SHE HAD PURCHASED THE KETONE TEST STRIPS THAT MORNING AND THAT THE BOX HAD BEEN SEALED BUT THE VIAL WAS OPENED. THE KETONE TEST STRIPS ARE EXPIRED - MANUFACTURER¿S EXPIRATION DATE IS 12/22/2021. CUSTOMER DID NOT PERFORM ANY TESTS USING THIS VIAL. CUSTOMER STATED THAT SHE GOT A SECOND VIAL, AND THAT VIAL IS WORKING AND IN DATE AS PER CUSTOMER (SHE DID NOT PROVIDE THE LOT # OF THE NEW BOTTLE). THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15751376 ↗
• MalfunctionOct 25, 2022Unexpected Color; Unexpected Color

  CONSUMER REPORTED COMPLAINT FOR THE KETONE TEST STRIPS. COMPLAINT WAS REPORTED VIA E-MAIL. CUSTOMER'S E-MAIL STATED THAT THE KETONE TEST STRIPS "DON¿T WORK AT ALL" AND THAT "THE COLOR JUST TURNS MUDDY LOOKING AND DOES NOT COME CLOSE TO ANYTHING ON THE COLOR CHART." NO SYMPTOMS AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED. CUSTOMER DID NOT PROVIDE CONTACT TELEPHONE NUMBER; EMAIL RESPONSE HAD BEEN SENT TO CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666279 ↗
• MalfunctionOct 14, 2022Unsealed Device Packaging; Unsealed Device Packaging

  CONSUMER REPORTED COMPLAINT FOR OPEN VIAL OF KETONE TEST STRIPS. CUSTOMER STATED THAT THE BOX WAS NOT DAMAGED BUT WHEN SHE OPENED THE BOX, THE VIAL WAS PARTIALLY OPENED. NO TESTS WERE PERFORMED USING THIS VIAL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15605693 ↗
• MalfunctionJul 22, 2022Material Discolored; Material Discolored

  CONSUMER REPORTED COMPLAINT FOR THE KETONE TEST STRIPS. CUSTOMER STATED THAT WHEN HE OPENED THE VIAL THE KETONE TEST STRIPS HAD BEEN GREY IN COLOR. CUSTOMER ALSO STATED THAT THE TEST STRIPS DID NOT CHANGE COLOR WHEN HE TESTED. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THIS IS THE FIRST TIME THE CUSTOMER IS USING THE PRODUCT OUT OF THE PACKAGE. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING AREA. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/13/2023 AND OPEN VIAL DATE WAS NOT DISCLOSED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS AND NO MEDICAL ATTENTION RELATED TO THE USE OF THE PRODUCT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15084571 ↗
• MalfunctionMay 20, 2022Material Discolored; Material Discolored

  CONSUMER REPORTED COMPLAINT FOR THE KETONE TEST STRIPS. CUSTOMER STATED THAT THE PACKAGE WAS NOT OPENED OR DAMAGED WHEN RECEIVED. CUSTOMER STATED THE TEST STRIP VIAL WAS SEALED AND WHEN SHE OPENED IT, THE COLOR ON THE TEST STRIP PAD WAS BLUE IN COLOR INSTEAD OF BEIGE. CUSTOMER DID NOT PERFORM ANY TEST USING THE TEST STRIPS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS AND MEDICAL ATTENTION RELATED TO THE USE OF THE PRODUCT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14454861 ↗
• MalfunctionApr 22, 2022Unsealed Device Packaging; Unsealed Device Packaging

  CONSUMER REPORTED COMPLAINT FOR THE KETONE TEST STRIPS. CUSTOMER STATED HE HAD PURCHASED 100 COUNT (TWO VIALS) OF THE KETONE TEST STRIPS ON (B)(6) 2022 AND THAT THE LID ON ONE OF THE VIALS HAD BEEN OPEN. CUSTOMER STATED THE SECOND VIAL HAD BEEN SEALED AND CLOSED. CUSTOMER STATED HE HAD USED ONE OF THE TEST STRIPS TO PERFORM A TEST ON (B)(6) 2022. CUSTOMER STATED HE WAS NOT CONCERNED WITH THE RESULT OBTAINED AND DID NOT RECALL WHAT THE RESULT WAS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187398 ↗
• MalfunctionApr 20, 2022Material Discolored; No Device Output; Material Discolored; No Device Output

  CONSUMER REPORTED COMPLAINT FOR THE KETONE TEST STRIPS. THE CUSTOMER STATED THAT THE TEST STRIPS WERE POSSIBLY GREY IN COLOR WHEN THE PACKAGE WAS FIRST OPENED. CUSTOMER ALSO STATED THAT TEST STRIPS WERE NOT CHANGING COLOR WHEN TESTING. CUSTOMER IS USING THE KETONE TEST STRIPS FOR A KETONE DIET. THE TEST STRIP MANUFACTURER'S EXPIRATION DATE IS 02/21/2023; OPEN VIAL DATE IS (B)(6) 2022. THE TEST STRIPS ARE NOT BEING STORED ACCORDING TO SPECIFICATION (KITCHEN). THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF KETONE TEST STRIPS THAT HAD BEEN STORED CORRECTLY. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS AND MEDICAL ATTENTION RELATED TO THE USE OF THE PRODUCT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164325 ↗
• MalfunctionFeb 18, 2022Material Discolored; Material Discolored

  CONSUMER REPORTED COMPLAINT FOR THE KETONE TEST STRIPS. CUSTOMER STATED THAT WHEN HE OPENED THE VIAL, THE PADDING ON THE KETONE TEST STRIPS WERE ALL GREY IN COLOR. CUSTOMER STATED THAT THE PRODUCT HAD BEEN SEALED AND INTACT WHEN PURCHASED. THE KETONE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/23/2022 AND OPEN VIAL DATE IS 01/23/2022. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS AND MEDICAL ATTENTION RELATED TO THE USE OF THE PRODUCT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559860 ↗
• MalfunctionFeb 16, 2022No Device Output; No Device Output

  CONSUMER REPORTED COMPLAINT FOR NEGATIVE/ NO CHANGE TRACE RESULTS FOR THE KETONE TEST STRIPS. CUSTOMER STATED THAT WHEN PERFORMING A URINE TEST THE KETONE TEST STRIPS DID NOT CHANGE COLOR. CUSTOMER IS USING THE KETONE TEST STRIPS FOR THE KETO DIET. DURING THE CALL, A URINE TEST WAS PERFORMED BY THE CUSTOMER AND THE TEST STRIPS DID NOT SHOW NEGATIVE / NO CHANGE TRACE RESULTS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATES THAT SHE IS NOT SURE SHE SHOULD BE EXPECTING A COLOR CHANGE. CUSTOMER STATES THAT SHE WILL TRY TO USE IT AGAIN AND WILL CALL US BACK IF SHE HAVE ANY QUESTIONS NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13546214 ↗
• MalfunctionDec 15, 2021Unsealed Device Packaging; Unsealed Device Packaging

  CONSUMER REPORTED COMPLAINT FOR THE KETONE TEST STRIPS. CUSTOMER STATED SHE HAD PURCHASED 100 COUNT (TWO VIALS OF 50) OF THE KETONE TEST STRIPS AND ONE OF THE TEST STRIP VIALS HAD BEEN PARTIALLY OPEN WHEN RECEIVED. CUSTOMER STATED THAT THE BOX/SEAL DID NOT APPEAR TO BE TAMPERED WITH. THE CUSTOMER IS USING THE PRODUCT FOR THE FIRST TIME OUT OF THIS PACKAGE. CUSTOMER HAD TESTED USING TEST STRIPS FROM THE VIAL (NEGATIVE). THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014085 ↗
• MalfunctionDec 13, 2021Material Discolored; No Device Output; Material Discolored; No Device Output

  CONSUMER REPORTED COMPLAINT FOR THE KETONE TEST STRIPS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER, HER (B)(6) SON. MOTHER STATED THAT THE DAY PRIOR SHE HAD OPENED A VIAL OF THE KETONE TEST STRIPS AND THE STRIPS WERE "CHARCOAL GRAY" IN COLOR. MOTHER STATED THE TEST STRIPS WON'T CHANGE COLOR WHEN USED TO TEST. MOTHER STATED THAT THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 08/14/2022. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. CUSTOMER DECLINED TO PERFORM A TEST DURING THE CALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12987575 ↗
• MalfunctionDec 9, 2021Material Discolored; Material Discolored

  CONSUMER REPORTED COMPLAINT FOR THE DISCOLORATION OF KETONE TEST STRIPS (GRAY). COMPLAINT WAS RECEIVED VIA E-MAIL. CUSTOMER STATED THAT HE HAD PURCHASED 100 COUNT (TWO VIALS) OF THE KETONE TEST STRIPS AND THAT THE TEST STRIPS IN ONE OF THE VIALS WERE GRAY IN COLOR. NO FURTHER INFORMATION WAS PROVIDED. E-MAIL RESPONSE HAD BEEN SENT TO CUSTOMER REQUESTING CUSTOMER PROVIDE TELEPHONE NUMBER TO CONTACT FOR FURTHER ASSISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967390 ↗
• MalfunctionNov 16, 2021Material Discolored; Material Discolored

  CONSUMER REPORTED COMPLAINT FOR THE KETONE TEST STRIPS. CUSTOMER STATED SHE HAD PURCHASED 100 COUNT (TWO VIALS) OF THE KETONE TEST STRIPS AND THAT THE PADDING ON THE TEST STRIPS IN ONE OF THE VIALS WAS GREY IN COLOR. CUSTOMER DID NOT REPORT ANY CONCERN WITH THE KETONE TEST STRIPS FROM THE OTHER VIAL, AND STATED THAT THEY WERE THE CORRECT COLOR. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THIS THE FIRST TIME THE CUSTOMER IS USING THE PRODUCT OUT OF THIS PACKAGE. CUSTOMER IS USING THE KETONE TEST STRIPS FOR DIETARY PURPOSES. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. CUSTOMER DECLINED TO PERFORM A TEST DURING THE CALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819128 ↗
• MalfunctionNov 7, 2021Unsealed Device Packaging; Unsealed Device Packaging

  CONSUMER REPORTED COMPLAINT FOR THE KETONE TEST STRIPS. CUSTOMER STATED THAT THE KETONE TEST STRIP VIAL HAD BEEN OPEN IN THE SEALED BOX WHEN RECEIVED. CUSTOMER STATED THAT THE BOX DID NOT APPEAR TO BE TAMPERED WITH. THE CUSTOMER STATED HE DID NOT USE ANY OF THE KETONE TEST STRIPS FROM THE VIAL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12759186 ↗
• MalfunctionNov 2, 2021Material Discolored; Material Discolored

  CONSUMER REPORTED COMPLAINT FOR PHYSICAL DEFECT OF THE KETONE TEST STRIPS. CUSTOMER STATED THE KETONE TEST STRIP PADS ARE GREY/BROWN IN COLOR. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (BATHROOM). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/30/2022 AND TEST STRIPS WERE OPENED ONE MONTH AGO. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12738523 ↗
• MalfunctionNov 1, 2021No Device Output; No Device Output

  CONSUMER REPORTED COMPLAINT FOR NEGATIVE/NO CHANGE TRACE RESULTS OF THE KETONE TEST STRIPS. CUSTOMER STATED THAT THE COLOR DOES NOT CHANGE WHEN HE TESTS. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/21/2023 AND CUSTOMER STATED HE HAD PURCHASED THE TEST STRIPS THREE DAYS AGO. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE CUSTOMER IS USING THE KETONE TEST STRIPS FOR A KETO DIET. CUSTOMER STATED THAT HE HAD NO SOLID FOOD FOR THE PAST FEW DAYS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. OFFERED TO REPLACE THE STRIPS BUT CUSTOMER STATES THAT HE WILL CONTINUE TO USE THEM AND SEE IF THEY CHANGE AND THEN CALL US BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12732970 ↗
• MalfunctionOct 22, 2021No Device Output; No Device Output

  CONSUMER REPORTED COMPLAINT FOR THE KETONE TEST STRIPS, STATING THE TEST STRIP DID NOT CHANGE COLOR WHEN PERFORMING A TEST. CUSTOMER STATED SHE PURCHASED THE KETONE TEST STRIPS THAT DAY; THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/19/2022. CUSTOMER STATED THE VIAL HAD BEEN SEALED WHEN PURCHASED. NO SYMPTOMS OR MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. COORDINATOR HAD INITIALLY SPOKEN WITH CUSTOMER AND TRANSFERRED CUSTOMER'S INFORMATION TO TECHNICIAN. TECHNICIAN WAS UNABLE TO CONTACT THE CUSTOMER VIA TELEPHONE, NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12685777 ↗
• MalfunctionOct 21, 2021Contamination; No Device Output; Contamination; No Device Output

  CONSUMER REPORTED COMPLAINT FOR THE KETONE TEST STRIPS. SISTER IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER STATED THE KETONE TEST STRIPS ARE PALE AND NOT TURNING COLOR. EXPLAINED TO CUSTOMER THAT THE COLOR ON THE PAD IS ALMOST PEACH IN COLOR AS SHOWN ON THE COLOR GRID ON THE VIAL AND NOT EXACTLY WHITE. EXPLAINED TO CUSTOMER THAT NO COLOR CHANGE MEANS NO KETONES PRESENT. REFERRED CUSTOMER BACK TO HER DOCTOR TO REVIEW DIET EXPECTATIONS. CUSTOMER STATED SHE IS SUPPOSED TO DOCUMENT HER KETONE AMOUNT DAILY. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THIS WAS THE FIRST TIME CUSTOMER USED THE PRODUCT OUT OF THIS PACKAGE. CUSTOMER STATED THAT THE TEST STRIP PADS ARE NOT ALL WHITE AND APPEARED USED. DURING THE CALL A URINE TEST WAS NOT PERFORMED BY THE CUSTOMER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12673052 ↗
• MalfunctionOct 15, 2021Unexpected Color; Unexpected Color

  CONSUMER REPORTED COMPLAINT FOR THE KETONE TEST STRIPS (PHYSICAL DEFECT/COLOR DOES NOT MATCH CHART ON VIAL). COMPLAINT WAS INITIALLY REPORTED VIA E-MAIL AND CUSTOMER WAS CONTACTED VIA TELEPHONE. CUSTOMER STATED SHE HAD PURCHASED A 50 COUNT VIAL OF TEST STRIPS AND THAT THEY TURNED BROWN WHEN SHE PERFORMED A TEST. CUSTOMER STATED THE BROWN COLOR IS VERY DIFFERENT THAN THE COLOR SHE EXPECTED AND IS USED TO. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/27/2022 AND THE TEST STRIPS WERE OPENED ONE WEEK PRIOR TO CALL. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (BATHROOM). THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE CUSTOMER IS USING THE KETONE TEST STRIPS FOR A KETO DIET. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12638300 ↗
• MalfunctionOct 8, 2021Material Discolored; Material Discolored

  CONSUMER REPORTED COMPLAINT FOR PHYSICAL DEFECT OF THE KETONE TEST STRIPS. CUSTOMER STATED SHE HAD JUST PURCHASED 100 COUNT (TWO VIALS) OF THE KETONE TEST STRIPS. CUSTOMER STATED THE TEST STRIPS IN ONE VIAL WERE GREY IN COLOR AND THE TEST STRIPS IN THE OTHER VIAL WERE PINK/FLESH TONE IN COLOR. CUSTOMER STATED SHE HAD NOT USED ANY OF THE TEST STRIPS FROM THE VIAL WHERE THE TEST STRIPS HAD BEEN GREY IN COLOR. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER AND THERE WAS NO EVIDENCE OF THE PRODUCT BEING USED PREVIOUSLY. THE TEST STRIP MANUFACTURER¿S EXPIRATION DATE IS 08/16/2022 AND CUSTOMER STATED SHE IS STORING AND HANDLING THE TEST STRIPS CORRECTLY (LOCATION UNDISCLOSED). THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. CUSTOMER DECLINED TO PERFORM A TEST DURING THE CALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598119 ↗
• MalfunctionOct 8, 2021No Device Output; No Device Output

  CONSUMER REPORTED COMPLAINT FOR NEGATIVE/ NO CHANGE TRACE RESULTS WHEN USING THE KETONE TEST STRIPS. CUSTOMER STATED SHE HAD PURCHASED THE 50 COUNT VIAL OF KETONE TEST STRIPS ON (B)(6) 2021. CUSTOMER STATED SHE HAD BEEN USING THE KETONE TEST STRIPS FOR THE PAST TWO DAYS AND HAD NOT SEEN ANY CHANGES IN HER TEST RESULTS. CUSTOMER STATED SHE HAS BEEN FOLLOWING THE KETO DIET DURING THIS TIME AND THAT THERE SHOULD BE SOME CHANGE IN HER RESULTS. CUSTOMER IS USING THE PROPER TESTING TECHNIQUE. CUSTOMER STATED HER HUSBAND HAD ALSO TESTED USING THE KETONE TEST STRIPS AND ALSO HAD NO CHANGE. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION (LOCATION NOT DISCLOSED); THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/23/2022. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. CUSTOMER DECLINED TO PERFORM A TEST DURING THE CALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12597908 ↗
• MalfunctionAug 27, 2021Material Discolored; No Device Output; Material Discolored; No Device Output

  CONSUMER REPORTED COMPLAINT FOR THE KETONE TEST STRIPS. COMPLAINT WAS INITIALLY REPORTED VIA E-MAIL AND THEN BY TELEPHONE. CUSTOMER STATED SHE HAD PURCHASED 2 VIALS OF 50 TEST STRIPS. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CUSTOMER STATED THE TIPS OF THE TEST STRIPS FROM THE FIRST VIAL WERE GREY IN COLOR AND THOSE FROM THE SECOND VIAL WERE BEIGE. CUSTOMER TESTED USING BOTH VIALS AND STATED THE FIRST VIAL PROVIDED A NEGATIVE TRACE AND THE SECOND VIAL SHOWED MODERATE. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/16/2022. THE PRODUCT STORAGE AND OPEN VIAL DATE WERE NOT DISCLOSED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. THE CUSTOMER DECLINED TO PERFORM A URINE TEST DURING THE CALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380525 ↗
• MalfunctionAug 20, 2021Material Discolored; Material Discolored

  CONSUMER REPORTED COMPLAINT FOR PHYSICAL DEFECT OF THE KETONE TEST STRIPS. CUSTOMER HAD PURCHASED 100 COUNT (TWO VIALS) OF THE KETONE TEST STRIPS AND STATED THAT THE TEST STRIPS IN ONE OF THE VIALS WERE GREY IN COLOR. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN PURCHASED BY THE CUSTOMER. CUSTOMER STATED THIS WAS THE FIRST TIME USING THE PRODUCT OUT OF THE PACKAGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. CUSTOMER DECLINED TO PERFORM A TEST DURING THE CALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12348885 ↗
• MalfunctionAug 18, 2021Material Discolored; Material Discolored

  CONSUMER REPORTED COMPLAINT FOR THE KETONE TEST STRIPS; COMPLAINT WAS REPORTED VIA E-MAIL. CUSTOMER STATED THEY HAD RECENTLY PURCHASED THE TRUE PLUS KETONE TEST STRIPS (WITHIN THE LAST THREE WEEKS). CUSTOMER STATED THE TEST STRIPS DO NOT FUNCTION AS INTENDED, AND THAT THEY WERE A DIFFERENT COLOR (TAN) THEN OTHER TRUE PLUS KETONE TEST STRIPS THEY HAD. E-MAIL RESPONSE WAS SENT TO CUSTOMER REQUESTING CUSTOMER PROVIDE TELEPHONE NUMBER.

  Patient problems: Insufficient Information

  MAUDE report 12337791 ↗
• InjuryJul 29, 2021Material Discolored; Material Discolored

  CONSUMER REPORTED COMPLAINT OF THE KETONE TEST STRIPS COLOR NOT MATCHING THE CHART ON VIAL AFTER USE. THIS WAS THE FIRST TIME THE CUSTOMER WAS USING THE PRODUCT OUT OF THE PACKAGE. CUSTOMER STATED SHE HAD BEEN VOMITING EARLIER THAT MORNING. CUSTOMER STATED SHE HAD GONE TO PURCHASE THE KETONE TEST STRIPS, HAD PERFORMED A TEST, BUT THE TEST STRIP HAD TURNED BROWN; THE COLOR DID NOT MATCH THE CHART ON THE VIAL. AT THE TIME OF THE CALL THE CUSTOMER REPORTED SYMPTOMS OF NAUSEA AND TIRED. CUSTOMER STATED THAT SHE WAS GOING TO SEEK MEDICAL INTERVENTION DUE TO THE SYMPTOMS.

  Patient problems: Fatigue; Nausea; Vomiting

  MAUDE report 12245619 ↗