FreeStyle Lite 71026Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 00699073710260), received between Mar 10, 2017 and Feb 9, 2023 — classified as 37 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (73 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 105 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2023Incorrect, 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 52 MG/DL, 300 MG/DL, 42 MG/DL AND 51 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 16340179 ↗
• MalfunctionDec 29, 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 124 MG/DL AND 26 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 16068633 ↗
• MalfunctionJul 28, 2022Incorrect, 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 15127280 ↗
• MalfunctionJun 9, 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 372 MG/DL, 102 MG/DL AND 353 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 14647139 ↗
• MalfunctionJun 1, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED RECEIVING A LOW READING FROM THEIR ADC DEVICE. CUSTOMER REPORTED A LOW READING OF 120 MG/DL WHICH WAS LOWER THAN LAB READING OF 264 MG/DL. 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 14566826 ↗
• MalfunctionMay 20, 2022Incorrect, 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 14460845 ↗
• MalfunctionMay 11, 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 38 MG/DL, 148 MG/DL, 77 MG/DL, 252 MG/DL AND 388 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 14356051 ↗
• MalfunctionMay 5, 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 73 MG/DL, 166 MG/DL AND 425 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 14288981 ↗
• InjuryMar 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED RECEIVING UNSPECIFIED READINGS THAT WERE ERRATIC ON ADC DEVICE AND HE EXPERIENCED A LOSS OF CONSCIOUSNESS. CUSTOMER WAS SEEN BY A HEALTHCARE PROVIDER AND A READING OF 380 MG/DL WAS OBTAINED. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND RECEIVED UNSPECIFIED TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia; Loss of consciousness

  MAUDE report 13759215 ↗
• MalfunctionJan 21, 2022Incorrect, 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 13315432 ↗
• MalfunctionJan 11, 2022Incorrect, 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 23 MG/DL AND 236 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 13225798 ↗
• MalfunctionDec 21, 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 195 MG/DL, 21 MG/DL, 112 MG/DL, 74 MG/DL, 162 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 13056278 ↗
• MalfunctionNov 12, 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 12804412 ↗
• InjuryOct 8, 2021High Readings; High Readings

  THE WIFE OF CUSTOMER REPORTED A HIGH READING ISSUE WITH THE ADC BLOOD GLUCOSE METER, AND REPORTED THAT THE CUSTOMER "COLLAPSED". HOWEVER, NO TREATMENT WAS REQUIRED. THE CALLER STATED SHE WAS UNSURE IF THIS EVENT WAS DUE TO REPORTED ISSUE OR BECAUSE CUSTOMER JUST HAD PANCREATIC CANCER SURGERY. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 12598878 ↗
• InjuryOct 8, 2021High Readings; High Readings

  THE WIFE OF CUSTOMER REPORTED A HIGHER READING WITH THE ADC BLOOD GLUCOSE METER, AS COMPARED TO PARAMEDIC METER. THE WIFE REPORTED A ADC METER RESULT OF 89 MG/DL, AND INJECTED CUSTOMER WITH INSULIN. THE CUSTOMER SUBSEQUENTLY EXPERIENCED SEIZURE AND LOSS OF CONSCIOUSNESS. PARAMEDICS WERE CALLED AND THE WIFE GAVE CUSTOMER A GLUCOSE TABLET AND JUICE. A PARAMEDIC METER RESULT OF 34 MG/DL WAS OBTAINED AND CUSTOMER ADDITIONALLY TREATED WITH GLUCOSE VIA IV. PLEASE NOTE THAT A BLOOD GLUCOSE RESULT OF 89 MG/DL INDICATES CUSTOMER'S BLOOD GLUCOSE WAS WITHIN NORMAL RANGE AND GENERALLY DOES NOT NECESSITATE TREATMENT OF INSULIN INJECTION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Convulsion/Seizure; Hypoglycemia; Loss of consciousness

  MAUDE report 12598873 ↗
• MalfunctionSep 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 300 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 12529926 ↗
• MalfunctionSep 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED RECEIVING ERRATIC READINGS WITH THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 19 MG/DL AND 159 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 12529796 ↗
• MalfunctionSep 10, 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 340 MG/DL AND 77 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 12457264 ↗
• InjuryJul 1, 2021No Device Output; No Device Output

  CUSTOMER REPORTED BEING UNABLE TO TEST DUE TO THE ADC BLOOD GLUCOSE METER TURNING ON WITH BUTTON PRESS BUT NOT WITH TEST STRIP INSERTION. CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS "SWEATING, CHILLS, INABILITY TO SPEAK, INABILITY TO MOVE, DIFFICULTY SWALLOWING, WEAKNESS, SEIZURE AND A LOSS OF CONSCIOUSNESS". CUSTOMER HAD CONTACT WITH HEALTHCARE PROVIDER WHO DIAGNOSED HIM WITH HYPOGLYCEMIA AND TREATED WITH UNSPECIFIED IV TO INCREASE THE BLOOD GLUCOSE. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Convulsion/Seizure; Diaphoresis; Hypoglycemia; Loss of consciousness; Muscle Weakness/Atrophy

  MAUDE report 12101245 ↗
• MalfunctionJun 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 240 MG/DL, 440 MG/DL AND 121 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 12051461 ↗
• InjuryJun 23, 2021Device Displays Incorrect Message; Device Displays Incorrect Message

  CUSTOMER REPORTED RECEIVING AN ERROR MESSAGE ON THE DISPLAY OF HIS ADC BLOOD GLUCOSE METER AFTER BLOOD SAMPLE WAS APPLIED ON THE STRIP AND WAS THEREFORE UNABLE TO TEST. CUSTOMER FURTHER REPORTED THAT HE EXPERIENCED A MEDICAL EVENT AND WAS RUSHED TO HOSPITAL AS HIS GLUCOSE LEVELS WERE 585 MG/DL ON AN UNSPECIFIED METER. NO FURTHER INFORMATION WAS PROVIDED AS CUSTOMER REFUSED TO CONTINUE TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 12050077 ↗
• MalfunctionJun 10, 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 11973022 ↗
• InjuryMay 19, 2021Device Displays Incorrect Message; Device Displays Incorrect Message

  A ERROR MESSAGE WAS REPORTED WITH THE ADC METER. CUSTOMER WAS UNABLE TO OBTAIN READINGS DUE TO RECEIVING AN ERROR 3 MESSAGE, AND REPORTED RECEIVING UNSPECIFIED THIRD-PARTY TREATMENT. NO FURTHER DETAILS WERE REPORTED AS CUSTOMER COULD NOT TROUBLESHOOT FURTHER. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11852218 ↗
• InjuryApr 29, 2021High Readings; High Readings

  CUSTOMER'S WIFE REPORTED THAT HER HUSBAND RECEIVED A READING OF 179 MG/DL AT 6:35 P.M. ON HIS ADC BLOOD GLUCOSE METER AND WAS TREATED WITH 65 UNITS OF INSULIN AT 7 P.M. BEFORE DINNER. AFTER DINNER, CUSTOMER FELL ASLEEP, WAS UNRESPONSIVE AND EXPERIENCED SYMPTOMS DESCRIBED AS "JAW LOCKED, EYES HALF OPEN, CLAMMY SKIN" AND A LOSS OF CONSCIOUSNESS AND A READING OF 65 MG/DL WAS OBTAINED AT 7:20 P.M. ON AN UNSPECIFIED METER. PARAMEDICS WAS CALLED AND A READING OF 23 MG/DL WAS OBTAINED ON THE HCP METER AND HE WAS TREATED WITH A GLUCOSE SHOT VIA IV. AFTER 5 MINUTES, CUSTOMER WOKE UP AND WAS ABLE TO EAT PEANUT BUTTER, JELLY SANDWICH AND A READING OF 180 MG/DL ON AN UNSPECIFIED METER. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Diaphoresis; Hypoglycemia; Loss of consciousness

  MAUDE report 11745798 ↗
• InjuryApr 1, 2021High Readings; High Readings

  A HIGH READINGS ISSUE WAS REPORTED WITH THE USE OF THE ADC GLUCOSE METER. THE CUSTOMER REPORTED RECEIVING A ¿HI¿ (READINGS GREATER THAN 500 MG/DL) MESSAGE AND A 415 MG/DL SCAN ON THE SENSOR. THE CUSTOMER BECAME LIGHT-HEADED AND HE CONTACTED HIS DOCTOR WHO ADVISED HIM TO GO TO THE ER. AT THE ER, A READING OF 390 MG/DL WAS OBTAINED ON THE HCP METER AND AN UNSPECIFIED IV DRIP WAS ADMINISTERED AS TREATMENT. THE CUSTOMER WAS MONITORED IN THE ER FOR 5 HOURS AND NO ADDITIONAL TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11606220 ↗

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