FreeStyle 12101Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00699073121011), received between Aug 13, 2019 and Dec 17, 2020 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K092638); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2020High Readings; High Readings

  CALLER (CUSTOMER¿S GRAND DAUGHTER) REPORTED THE CUSTOMER¿S ADC BLOOD GLUCOSE METER WAS PROVIDING UNSPECIFIED HIGH READINGS THAT WERE "NOT NORMAL". CUSTOMER EXPERIENCED UNSPECIFIED SYMPTOMS OF HYPERGLYCEMIA AND STROKE AND WAS UNABLE TO SELF-TREAT. CUSTOMER HAD CONTACT WITH THE HEALTHCARE PROVIDER AND RECEIVED UNSPECIFIED TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 11028327 ↗
• InjuryMar 9, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED HAVING UNSPECIFIED READINGS ISSUE WITH THE USE OF ADC BLOOD GLUCOSE METER. ON AN UNSPECIFIED DATE, CUSTOMER FELT "VERY SICK, LIGHTHEADED AND HIGH BLOOD PRESSURE" AND WAS SEEN AT THE HOSPITAL WHERE AN UNSPECIFIED READING WAS OBTAINED ON THE HCP METER. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND RECEIVED UNSPECIFIED TREATMENT. CUSTOMER ADDITIONALLY REPORTED THAT SHE SELF-TREATED WITH UNKNOWN DOSE OF INSULIN BUT IT IS UNKNOWN IF IT WAS BEFORE GOING TO THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 9808544 ↗
• MalfunctionFeb 24, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 46 MG/DL, 126 MG/DL AND 46 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9746880 ↗
• MalfunctionAug 28, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED RECEIVING ERRATIC READINGS WHILE USING AN OMNIPOD DEVICE WITH ADC FREESTYLE TEST STRIPS. CUSTOMER REPORTED RECEIVING READINGS OF 39 MG/DL, 266 MG/DL AND 200 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8940167 ↗
• MalfunctionAug 13, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 456 MG/DL, 199 MG/DL AND 128 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8888517 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092638. One submission often covers many models, so check the product and lot details in each record.

• Z-1212-2014 · Feb 19, 2014 · Terminated
  FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test St
• Z-1211-2014 · Feb 19, 2014 · Terminated
  FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system opera