FreeStyle Lite 70817Recalls & reported problems
Abbott Diabetes Care Inc · FreeStyle Lite Blood Glucose Test Strips · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00699073708175), received between Jan 23, 2018 and Jan 23, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “High Readings” (1 report).
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
Device problems
- High Readings1
Patient problems
- Hypoglycemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 23, 2018High Readings; High Readings
CUSTOMER¿S MOTHER REPORTED CUSTOMER RECEIVED HIGH READINGS FROM HIS ADC BLOOD GLUCOSE METER. IT WAS FURTHER REPORTED THAT ON AN UNSPECIFIED DATE/TIME CUSTOMER RECEIVED READINGS OF ¿300 OR HIGHER¿ FROM HIS METER, WHICH WERE HIGHER THAN HE FELT. PARAMEDICS WERE CALLED AND UPON ARRIVAL RECEIVED THE FOLLOWING READINGS FROM THEIR METER: 27 MG/DL, 43 MG/DL AND 49 MG/DL. IT IS UNKNOWN HOW MUCH TIME MAY HAVE ELAPSED BETWEEN THE CUSTOMER'S AND PARAMEDIC'S RESULTS. CUSTOMER WAS TREATED WITH AN INTRAVENOUS INFUSION OF D50, IN ADDITION TO BEING GIVEN AN UNSPECIFIED ¿INJECTION TO BRING HIS BLOOD SUGAR BACK UP¿. NO FURTHER TREATMENT WAS REQUIRED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: Hypoglycemia
MAUDE report 7214422 ↗
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-0486-2014 · Nov 18, 2013 · TerminatedFreeStyle 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
- Z-0485-2014 · Nov 18, 2013 · TerminatedFreeStyle 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
Other Glucose dehydrogenase, glucose devices
- OneTouch Verio IQ 022-275LifeScan Europe GmbH · Glucose dehydrogenase, glucose6,035 reports
- OneTouch Verio 022-659LifeScan Europe GmbH · Glucose dehydrogenase, glucose4,219 reports
- TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 50 Test StripsTrividia Health, Inc. · Glucose Dehydrogenase, Glucose2 deaths2,548 reports
- FreeStyle Lite 70805Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose2,366 reports
- FreeStyle Freedom Lite 70920Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose1,037 reports
- FreeStyle Freedom Lite 70914Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose760 reports
- Accu-Chek Guide 08256292001Roche Diagnostics Operations, Inc. · Glucose Dehydrogenase, Glucose476 reports
- ACCU-CHEK AVIVA PLUS 06908268001Roche Diagnostics Operations, Inc. · Glucose Dehydrogenase, Glucose472 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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