FreeStyle Lite 70822Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00699073708229), received between Apr 21, 2017 and Sep 2, 2022 — classified as 36 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (56 reports).

2 other recalls cover devices cleared under the same FDA submission (K092602); 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 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC DEVICE. CUSTOMER REPORTED RECEIVING READINGS OF 397 MG/DL, 199 MG/DL, 97 MG/DL, 404 MG/DL, AND 209 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15352610 ↗
• MalfunctionApr 12, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC DEVICE. CUSTOMER REPORTED RECEIVING READINGS OF 48MG/DL AND 310 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14084413 ↗
• InjuryMar 23, 2022No Device Output; No Device Output

  A CALLER REPORTED THAT HER HUSBAND WAS UNABLE TO TEST USING THE ADC METER AS IT WOULD NOT POWER ON WITH STRIP INSERTION. THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AND A GLUCOSE READING OF 44 MG/DL WAS OBTAINED ON THE METER AFTER MULTIPLE, REPEATED ATTEMPTS. DURING THE COURSE OF TROUBLESHOOTING, IT WAS DETERMINED THAT THE CUSTOMER WAS NOT FULLY INSERTING THE TEST STRIP. AN AMBULANCE WAS CALLED AND CUSTOMER WAS TRANSPORTED TO THE HOSPITAL WHERE THEY RECEIVED GLUCOSE GEL FOR TREATMENT OF HYPOGLYCEMIA AND HOSPITALIZED FOR THREE DAYS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 13862972 ↗
• InjuryJun 10, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN ERRATIC READINGS ISSUE WAS REPORTED WITH THE ADC METER. CUSTOMER REPORTED RECEIVING "DIFFERENT READINGS" AND EXPERIENCING SYMPTOMS DESCRIBED AS DIZZINESS AND SHAKING AND REPORTEDLY LOST CONSCIOUSNESS TWICE. CUSTOMER SELF-TREATED (UNSPECIFIED) AND WAS "RUSHED TO THE HOSPITAL" WHERE HER MEDICATION WAS ADJUSTED. NO TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Dizziness; Loss of consciousness; Shaking/Tremors

  MAUDE report 11978842 ↗
• InjuryMay 12, 2021No Device Output; Unable to Obtain Readings; No Device Output; Unable to Obtain Readings

  A CUSTOMER REPORTED THE ADC BLOOD GLUCOSE METER DID NOT GIVE ANY RESULTS AFTER THE BLOOD SAMPLE WAS APPLIED TO THE TEST STRIP AS IT WOULD NOT ADVANCE BEYOND THE ¿APPLY BLOOD¿ SCREEN. THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AND RECEIVED UNSPECIFIED THIRD-PARTY MEDICAL TREATMENT. NO FURTHER INFORMATION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 11815742 ↗
• MalfunctionApr 14, 2021Incorrect, 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 15 MG/DL AND 135 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 11668155 ↗
• MalfunctionApr 14, 2021Incorrect, 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 419 MG/DL AND 88 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: Hyperglycemia

  MAUDE report 11664499 ↗
• MalfunctionApr 8, 2021Incorrect, 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 187 MG/DL, 408 MG/DL, AND 54 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11638027 ↗
• MalfunctionApr 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO EITHER THE C, D, OR E ZONE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617967 ↗
• MalfunctionMar 16, 2021Incorrect, 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 65 MG/DL, 200 MG/DL AND 40 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 11494662 ↗
• MalfunctionFeb 23, 2021Incorrect, 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 79 MG/DL, 260 MG/DL AND 275 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11365180 ↗
• MalfunctionFeb 10, 2021Failure to Power Up; Failure to Power Up

  THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307533 ↗
• InjuryJan 13, 2021Device Displays Incorrect Message; Device Displays Incorrect Message

  A CUSTOMER REPORTED RECEIVING AN "ERROR-3" MESSAGE UPON ATTEMPTING TO TEST USING THE ADC BLOOD GLUCOSE METER. THE CUSTOMER WAS RUSHED TO THE EMERGENCY ROOM AND RECEIVED UNSPECIFIED TREATMENT. NO FURTHER INFORMATION WAS PROVIDED AS THE CUSTOMER REFUSED TO CONTINUE TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11164113 ↗
• MalfunctionDec 29, 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 500 MG/DL AND 60 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 11087177 ↗
• MalfunctionDec 28, 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 79 MG/DL, 290 MG/DL AND 217 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11082815 ↗
• MalfunctionDec 23, 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 501 MG/DL, 130 MG/DL, 465 MG/DL AND 120 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11065230 ↗
• InjuryNov 25, 2020No Device Output; Unable to Obtain Readings; No Device Output; Unable to Obtain Readings

  A CUSTOMER REPORTED THE BLOOD GLUCOSE TEST WOULD NOT START WITH TEST SAMPLE INSERTION, WITH THE ADC BLOOD GLUCOSE METER. ON (B)(6)2020, THE CUSTOMER WENT TO A WALK-IN CLINIC, BUT DID NOT RECEIVE DIABETES RELATED TREATMENT. THE CUSTOMER THEN BEGAN EXPERIENCING SYMPTOMS OF DEHYDRATION, PAIN, DIARRHEA, AND SWEATING, AND SELF-PRESENTED AT A HOSPITAL ON (B)(6)2020. THE CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA, AND REPORTED RECEIVING UNSPECIFIED TREATMENT FOR DEHYDRATION AND PAIN RELIEVERS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Dehydration; Diarrhea; Hyperglycemia; Pain; Sweating

  MAUDE report 10907103 ↗
• InjuryNov 25, 2020Low Readings; Low Readings

  A LOW READINGS ISSUE WAS REPORTED WITH THE ADC METER. CUSTOMER REPORTED EXPERIENCING NAUSEA AND HAVING CONTACT WITH AN HCP WHO OBTAINED A READING OF 168 MG/DL ON THEIR DEVICE COMPARED TO A SENSOR SCAN RESULT OF 122 MG/DL. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND ADMINISTERED INTRAVENOUS FLUIDS FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia; Nausea

  MAUDE report 10901023 ↗
• InjuryNov 10, 2020High Readings; High Readings

  THE WIFE OF A CUSTOMER REPORTED HE OBTAINED A HIGHER READING THAN HOW HE FELT WHEN TESTING ON THE ADC BLOOD GLUCOSE METER, ON (B)(6) -2020. AS A RESULT OF THE HIGH GLUCOSE TEST, THE CUSTOMER SELF-TREATED WITH INSULIN (DOSE UNKNOWN), AND SUBSEQUENTLY "FELT VERY CONFUSED" AND LOST CONSCIOUSNESS. PARAMEDICS WERE CALLED AND A BLOOD GLUCOSE TEST OF 30 MG/DL WAS OBTAINED ON THE EMERGENCY SERVICES METER. THE CUSTOMER WAS TREATED WITH AN UNSPECIFIED IV MEDICATION FOR A DIAGNOSIS OF HYPOGLYCEMIA. A FOLLOW-UP BLOOD GLUCOSE OF 40 MG/DL WAS OBTAINED AT THE HOSPITAL ON THE HOSPITAL METER. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Confusion/ Disorientation; Hypoglycemia; Loss of consciousness

  MAUDE report 10817211 ↗
• InjuryNov 3, 2020No Device Output; No Device Output

  CALLER REPORTED ON BEHALF OF THE CUSTOMER THAT HE WAS UNABLE TO TEST DUE TO HIS ADC BLOOD GLUCOSE METER TURNING ON WITH BUTTON PRESS BUT NOT WITH TEST STRIP INSERTION. CUSTOMER EXPERIENCED SEIZURE AND LOSS OF CONSCIOUSNESS. PARAMEDICS WAS CALLED AND UPON THEIR ARRIVAL, A READING OVER 500 MG/DL WAS OBTAINED ON AN UNSPECIFIED METER. CUSTOMER WAS TREATED WITH INSULIN AND WAS TRANSPORTED TO HOSPITAL. CUSTOMER WAS IN ICU FOR 2 WEEKS WHERE HE RECEIVED UNSPECIFIED TREATMENT AND HE WAS AT NURSING REHAB FOR A MONTH. CUSTOMER WAS PRESCRIBED METFORMIN BEFORE HE WAS DISCHARGED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia; Loss of consciousness; Seizures

  MAUDE report 10781208 ↗
• InjuryOct 28, 2020Low Readings; Low Readings

  A CUSTOMER REPORTED LOW GLUCOSE RESULTS THAN HOW THEY FEEL WHEN TESTING ON THE ADC METER. IN (B)(6) 2020, THE CUSTOMER OBTAINED A BLOOD GLUCOSE OF 83MG/DL AND EXPERIENCED DIZZINESS, SHAKINESS, THIRST, AND CHEST PAIN WHICH SHE STATED MEANT TO HER THAT HER BLOOD GLUCOSE WAS HIGH. EMERGENCY SERVICES WERE CALLED AND AFTER AN UNSPECIFIED AMOUNT OF TIME, THE CUSTOMER WAS TAKEN TO THE HOSPITAL WHERE UNKNOWN BLOOD GLUCOSE AND BLOOD PRESSURE WERE OBTAINED AND THE CUSTOMER WAS GIVEN AN IV AND TREATED WITH "METFORMIN, ASPIRIN, METOPROLOL AND SPIRONOL," WHICH IS A NEW MEDICATION FOR THE CUSTOMER. THE CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND HOSPITALIZED FOR 3 DAYS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Chest Pain; Dizziness; Hyperglycemia

  MAUDE report 10752726 ↗
• InjuryOct 28, 2020No Device Output; No Device Output

  CUSTOMER REPORTED BEING UNABLE TO TEST WITH HER ADC BLOOD GLUCOSE METER DUE TO THE TEST NOT STARTING AFTER THE BLOOD SAMPLE WAS APPLIED. CUSTOMER WAS BROUGHT TO HOSPITAL WHERE SHE WAS DIAGNOSED WITH HYPERGLYCEMIA AND WAS TREATED WITH UNSPECIFIED IV AND UNSPECIFIED PRESCRIPTION MEDICATION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 10751897 ↗
• InjuryOct 19, 2020No Device Output; No Device Output

  CUSTOMER REPORTED BEING UNABLE TO TEST WITH HER ADC BLOOD GLUCOSE METER DUE TO THE TEST NOT STARTING AFTER THE BLOOD SAMPLE WAS APPLIED. CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS "NOT FEELING WELL, HEAD SPINNING AND WOOZY" AND WAS UNABLE TO SELF-TREAT. CUSTOMER WAS RUSHED TO HOSPITAL WHERE SHE WAS DIAGNOSED WITH HYPERGLYCEMIA AND DEHYDRATION AND WAS TREATED WITH UNSPECIFIED IV AND ORAL MEDICATION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Dizziness; Hyperglycemia; Malaise

  MAUDE report 10701026 ↗
• MalfunctionSep 28, 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 42 MG/DL, 118 MG/DL AND 265 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 10596733 ↗
• MalfunctionJul 31, 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 298 MG/DL, 92 MG/DL AND 280 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 10350008 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092602. One submission often covers many models, so check the product and lot details in each record.

• Z-0485-2014 · Nov 18, 2013 · Terminated
  FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6
• Z-0486-2014 · Nov 18, 2013 · Terminated
  FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC 6 99073 70819 9; - 50 count UPC 6 99073 70822 9 - 50 count