GenUltimate! 100-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00868906000100), received between Nov 25, 2019 and Mar 20, 2020 — classified as 10 malfunctions.

The most frequently reported specific device problem is “High Readings” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2020High Readings; High Readings

  A CUSTOMER COMPLAINT PROMPTED AN INVESTIGATION BY OUR COMPANY INTO A POTENTIAL PRODUCT MALFUNCTION. WE HAD THE CUSTOMER'S PRODUCT TESTED BY A 3RD-PARTY (INITIAL REPORTER) WITH WHOLE BLOOD AT A LOW GLUCOSE LEVEL AND A HIGH GLUCOSE LEVEL. THE STRIP READINGS WERE COMPARED TO THE GLUCOSE LEVELS, WHICH WERE MEASURED USING A YSI 2300 STAT PLUS GLUCOSE ANALYZER. BY THIS METHOD, IT WAS DETERMINED THAT THE CUSTOMER'S PRODUCT WAS GIVING FALSELY HIGH RESULTS AT THE LOW GLUCOSE LEVEL, WHILE THE HIGH GLUCOSE LEVEL RESULTS WERE WITHIN ACCEPTABLE LIMITS.

  Patient problems: Not Applicable

  MAUDE report 9862935 ↗
• MalfunctionDec 18, 2019High Readings; High Readings

  A CUSTOMER COMPLAINT PROMPTED AN INVESTIGATION BY OUR COMPANY INTO POTENTIAL PRODUCT MALFUNCTION. WE HAD THE CUSTOMER'S PRODUCT TESTED BY A 3RD-PARTY (INITIAL REPORTER) AT A LOW GLUCOSE LEVEL AND A HIGH GLUCOSE LEVEL. THE STRIP READINGS WERE COMPARED TO THE GLUCOSE LEVELS, WHICH WERE MEASURED USING A YSI 2300 STAT PLUS GLUCOSE ANALYZER. BY THIS METHOD, IT WAS DETERMINED THAT THE CUSTOMER'S PRODUCT WAS GIVING FALSELY HIGH RESULTS AT BOTH THE LOW AND HIGH GLUCOSE LEVELS.

  Patient problems: Not Applicable

  MAUDE report 9491956 ↗
• MalfunctionNov 25, 2019High Readings; High Readings

  A CUSTOMER COMPLAINT PROMPTED AN INVESTIGATION BY OUR COMPANY INTO A POTENTIAL PRODUCT MALFUNCTION. WE HAD THE CUSTOMER'S PRODUCT TESTED BY A 3RD-PARTY (INITIAL REPORTER) WITH WHOLE BLOOD AT A LOW GLUCOSE LEVEL AND A HIGH GLUCOSE LEVEL. THE STRIP READINGS WERE COMPARED TO THE GLUCOSE LEVELS, WHICH WERE MEASURED USING A YSI 2300 STAT PLUS GLUCOSE ANALYZER. BY THIS METHOD, IT WAS DETERMINED THAT THE CUSTOMER'S PRODUCT WAS GIVING FALSELY HIGH RESULTS AT THE LOW GLUCOSE LEVEL, WHILE THE HIGH GLUCOSE LEVEL RESULTS WERE WITHIN ACCEPTABLE LIMITS.

  Patient problems: Not Applicable

  MAUDE report 9372448 ↗
• MalfunctionNov 25, 2019High Readings; High Readings

  A CUSTOMER COMPLAINT PROMPTED AN INVESTIGATION BY OUR COMPANY INTO POTENTIAL PRODUCT MALFUNCTION. WE RAN 10 CONTROL TESTS ON THE CUSTOMER'S PRODUCT USING ONE TOUCH ULTRA CONTROL SOLUTION AND A ONE TOUCH ULTRA 2 METER. WE THEN CALCULATED THE MEAN OF THOSE RESULTS AND FOUND THEM TO BE OUT OF RANGE. WE THEN HAD RETAINS FROM THE SAME LOT OF PRODUCT TESTED BY A 3RD-PARTY (INITIAL REPORTER) AT A LOW GLUCOSE LEVEL AND A HIGH GLUCOSE LEVEL. THE STRIP READINGS WERE COMPARED TO THE GLUCOSE LEVELS, WHICH WERE MEASURED USING A YSI 2300 STAT PLUS GLUCOSE ANALYZER. BY THIS METHOD, IT WAS DETERMINED THAT THE RETAIN SAMPLE PRODUCT WAS GIVING FALSELY HIGH RESULTS AT BOTH THE LOW AND HIGH GLUCOSE LEVELS.

  Patient problems: Not Applicable

  MAUDE report 9372443 ↗
• MalfunctionNov 25, 2019High Readings; High Readings

  A CUSTOMER COMPLAINT PROMPTED AN INVESTIGATION BY OUR COMPANY INTO POTENTIAL PRODUCT MALFUNCTION. WE HAD THE CUSTOMER'S PRODUCT TESTED BY A 3RD-PARTY (INITIAL REPORTER) AT A LOW GLUCOSE LEVEL AND A HIGH GLUCOSE LEVEL. THE STRIP READINGS WERE COMPARED TO THE GLUCOSE LEVELS, WHICH WERE MEASURED USING A YSI 2300 STAT PLUS GLUCOSE ANALYZER. BY THIS METHOD, IT WAS DETERMINED THAT THE CUSTOMER'S PRODUCT WAS GIVING FALSELY HIGH RESULTS AT BOTH THE LOW AND HIGH GLUCOSE LEVELS.

  Patient problems: Not Applicable

  MAUDE report 9372439 ↗
• MalfunctionNov 25, 2019High Readings; High Readings

  A CUSTOMER COMPLAINT PROMPTED AN INVESTIGATION BY OUR COMPANY INTO A POTENTIAL PRODUCT MALFUNCTION. WE HAD THE CUSTOMER'S PRODUCT TESTED BY A 3RD-PARTY (INITIAL REPORTER) WITH WHOLE BLOOD AT A LOW GLUCOSE LEVEL AND A HIGH GLUCOSE LEVEL. THE STRIP READINGS WERE COMPARED TO THE GLUCOSE LEVELS, WHICH WERE MEASURED USING A YSI 2300 STAT PLUS GLUCOSE ANALYZER. BY THIS METHOD, IT WAS DETERMINED THAT THE CUSTOMER'S PRODUCT WAS GIVING FALSELY HIGH RESULTS AT BOTH THE LOW AND HIGH GLUCOSE LEVELS.

  Patient problems: Not Applicable

  MAUDE report 9372438 ↗
• MalfunctionNov 25, 2019High Readings; High Readings

  A CUSTOMER COMPLAINT PROMPTED AN INVESTIGATION BY OUR COMPANY INTO POTENTIAL PRODUCT MALFUNCTION. WE HAD THE CUSTOMER'S PRODUCT TESTED BY A 3RD-PARTY (INITIAL REPORTER) AT A LOW GLUCOSE LEVEL AND A HIGH GLUCOSE LEVEL. THE STRIP READINGS WERE COMPARED TO THE GLUCOSE LEVELS, WHICH WERE MEASURED USING A YSI 2300 STAT PLUS GLUCOSE ANALYZER. BY THIS METHOD, IT WAS DETERMINED THAT THE CUSTOMER'S PRODUCT WAS GIVING FALSELY HIGH RESULTS AT BOTH THE LOW AND HIGH GLUCOSE LEVELS.

  Patient problems: Not Applicable

  MAUDE report 9372437 ↗
• MalfunctionNov 25, 2019High Readings; High Readings

  A CUSTOMER COMPLAINT PROMPTED AN INVESTIGATION BY OUR COMPANY INTO POTENTIAL PRODUCT MALFUNCTION. WE HAD THE CUSTOMER'S PRODUCT TESTED BY A 3RD-PARTY (INITIAL REPORTER) AT A LOW GLUCOSE LEVEL AND A HIGH GLUCOSE LEVEL. THE STRIP READINGS WERE COMPARED TO THE GLUCOSE LEVELS, WHICH WERE MEASURED USING A YSI 2300 STAT PLUS GLUCOSE ANALYZER. BY THIS METHOD, IT WAS DETERMINED THAT THE CUSTOMER'S PRODUCT WAS GIVING FALSELY HIGH RESULTS AT BOTH THE LOW AND HIGH GLUCOSE LEVELS.

  Patient problems: Not Applicable

  MAUDE report 9372431 ↗
• MalfunctionNov 25, 2019High Readings; High Readings

  A CUSTOMER COMPLAINT PROMPTED AN INVESTIGATION BY OUR COMPANY INTO A POTENTIAL PRODUCT MALFUNCTION. WE HAD THE CUSTOMER'S PRODUCT TESTED BY A 3RD-PARTY (INITIAL REPORTER) WITH WHOLE BLOOD AT A LOW GLUCOSE LEVEL AND A HIGH GLUCOSE LEVEL. THE STRIP READINGS WERE COMPARED TO THE GLUCOSE LEVELS, WHICH WERE MEASURED USING A YSI 2300 STAT PLUS GLUCOSE ANALYZER. BY THIS METHOD, IT WAS DETERMINED THAT THE CUSTOMER'S PRODUCT WAS GIVING FALSELY HIGH RESULTS AT THE LOW GLUCOSE LEVEL, WHILE THE HIGH GLUCOSE LEVEL RESULTS WERE WITHIN ACCEPTABLE LIMITS.

  Patient problems: Not Applicable

  MAUDE report 9372430 ↗
• MalfunctionNov 25, 2019High Readings; High Readings

  A CUSTOMER COMPLAINT PROMPTED AN INVESTIGATION BY OUR COMPANY INTO POTENTIAL PRODUCT MALFUNCTION. WE HAD THE CUSTOMER'S PRODUCT TESTED BY A 3RD-PARTY (INITIAL REPORTER) AT A LOW GLUCOSE LEVEL AND A HIGH GLUCOSE LEVEL. THE STRIP READINGS WERE COMPARED TO THE GLUCOSE LEVELS, WHICH WERE MEASURED USING A YSI 2300 STAT PLUS GLUCOSE ANALYZER. BY THIS METHOD, IT WAS DETERMINED THAT THE CUSTOMER'S PRODUCT WAS GIVING FALSELY HIGH RESULTS AT BOTH THE LOW AND HIGH GLUCOSE LEVELS.

  Patient problems: Not Applicable

  MAUDE report 9372429 ↗