FreeStyleRecalls & reported problems across all models

We found 4 models of FreeStyle by Abbott Diabetes Care Inc in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Aug 29, 2017 and Apr 23, 2021 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (6 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

FreeStyle recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 16, 2021Class IIOpen, Classified

   Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

   Z-1929-2021 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported FreeStyle problems

FreeStyle models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FreeStyle 70469

  Single use only blood lancet without an integral sharps injury prevention feature
  1 recall0 reports
• FreeStyle 12101

  SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
  5 reports
• FreeStyle 70792

  SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
  2 reports
• FreeStyle 12050

  Glucose dehydrogenase, glucose
  1 report

Recent FreeStyle adverse event reports

The 8 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2021Unable to Obtain Readings; Device Displays Incorrect Message; Unable to Obtain Readings; Device Displays Incorrect Message

  A CUSTOMER REPORTED HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO AN UNSPECIFIED ERROR MESSAGE RECEIVED ON THE ADC BLOOD GLUCOSE METER. THE CUSTOMER EXPERIENCED SYMPTOMS OF DIZZINESS, DISORIENTATION, AND COULD NOT WALK, AND WAS INCAPABLE OF SELF-TREATING. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL WHO DIAGNOSED HIM WITH HYPOGLYCEMIA AND GLUCOSE WAS ADMINISTERED INTRAVENOUSLY AS TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Confusion/ Disorientation; Dizziness; Hypoglycemia

  MAUDE report 11716446 ↗
• 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 ↗
• MalfunctionNov 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER'S SON REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 49 MG/DL AND 249 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: Insufficient Information

  MAUDE report 10819774 ↗
• 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 ↗
• MalfunctionAug 29, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER WITHIN 10 MINUTES. RESULTS OF 140 MG/DL AND 19 MG/DL WERE PLOTTED ON THE PARKES ERROR GRID. THE RESULTS 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 6827702 ↗

Other Abbott Diabetes Care Inc products

• FreeStyle Libre 314 models · 69,860 reports · 6 recalls
• FreeStyle Libre 3 Plus5 models · 52,808 reports · 2 recalls
• FreeStyle Libre 212 models · 30,420 reports · 2 recalls
• FreeStyle Libre 14 day5 models · 16,749 reports · 1 recall
• FreeStyle Lite9 models · 3,388 reports
• FreeStyle Libre 2 Plus4 models · 3,192 reports
• FreeStyle Freedom Lite5 models · 2,436 reports
• FreeStyle Libre7 models · 705 reports · 1 recall