KETO-DIASTIX® 2883Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10301932883509), received between Oct 3, 2019 and Nov 26, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Incorrect Measurement” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2019Incorrect Measurement; Incorrect Measurement

  AN ADVOCATE REPORTED THAT THE CUSTOMER RECEIVED A NEGATIVE RESULT FOR KETONES WITH THE KETOSTIX REAGENT STRIPS. THE CUSTOMER NORMALLY TAKES 26 UNITS OF INSULIN AT NIGHT AND 37 UNITS OF INSULIN IN THE MORNING. THE CUSTOMER'S BLOOD SUGAR LEVELS ROSE TO OVER 600 MG/DL, SO HE ATTEMPTED TO PERFORM A TEST WITH THE KETOSTIX AND RECEIVED A NEGATIVE RESULT FOR KETONES. THE CUSTOMER WAS VOMITING, SLEEPY AND LIGHTHEADED. THE ADVOCATE STATED THAT THE CUSTOMER WAS UNABLE TO MEDICATE AS THE KETOSTIX GAVE HIM NEGATIVE RESULT FOR KETONES. THE CUSTOMER WAS HOSPITALIZED. ANOTHER TEST WAS ATTEMPTED FROM THE KETOSTIX REAGENT STRIPS IN THE HOSPITAL, WHICH ALSO GAVE A NEGATIVE READING, SO THE BLOOD TEST WAS PERFORMED. THE TESTS RUN AND THE READINGS OBTAINED IN HOSPITAL WERE UNKNOWN. THE ADVOCATE GAVE 40 UNITS OF INSULIN TO THE CUSTOMER. THE ADVOCATE REFUSED TO RETURN THE REAGENT STRIPS FOR EVALUATION.

  Patient problems: Dizziness; Vomiting

  MAUDE report 9375319 ↗
• InjuryOct 3, 2019Incorrect Measurement; Incorrect Measurement

  AN ADVOCATE REPORTED THAT THE CUSTOMER RECEIVED A NEGATIVE RESULT FOR KETONES WITH THE KETO-DIASTIX REAGENT STRIPS. THE CUSTOMER NORMALLY TAKES 26 UNITS OF INSULIN AT NIGHT AND 37 UNITS OF INSULIN IN THE MORNING. THE CUSTOMER'S BLOOD SUGAR LEVELS ROSE TO OVER 600 MG/DL, SO HE ATTEMPTED TO PERFORM A TEST WITH THE KETO-DIASTIX AND RECEIVED A NEGATIVE RESULT FOR KETONES. THE CUSTOMER WAS VOMITING, SLEEPY AND LIGHTHEADED. THE ADVOCATE STATED THAT THE CUSTOMER WAS UNABLE TO MEDICATE AS THE KETO-DIASTIX GAVE HIM NEGATIVE RESULT FOR KETONES. THE CUSTOMER WAS HOSPITALIZED. ANOTHER TEST WAS ATTEMPTED FROM THE KETO-DIASTIX REAGENT STRIPS IN THE HOSPITAL, WHICH ALSO GAVE A NEGATIVE READING, SO THE BLOOD TEST WAS PERFORMED. THE TESTS RUN AND THE READINGS OBTAINED IN HOSPITAL WERE UNKNOWN. THE ADVOCATE GAVE 40 UNITS OF INSULIN TO THE CUSTOMER. THE ADVOCATE REFUSED TO RETURN THE REAGENT STRIPS FOR EVALUATION.

  Patient problems: Dizziness; Vomiting

  MAUDE report 9152838 ↗