CareSens N 164104-203Recalls & reported problems
i-SENS, Inc. · CareSens N Blood Glucose Test Strip · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885325000023), received between Jan 29, 2019 and Jan 29, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Readings” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- High Readings1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2019High Readings; High Readings
THE CUSTOMER CHECKED HIS BLOOD GLUCOSE AFTER EATING A FRUIT AND COFFEE BETWEEN 3 AND 4 P.M., AND IT WAS 87MG/DL. HOWEVER, HE HAD SYMPTOMS OF LOW BLOOD GLUCOSE. THEY CALLED THE PARAMEDICS, THEY CAME IN AND CHECKED HIS BLOOD GLUCOSE ABOUT 15 MINUTES LATER, AND IT WAS 37MG/DL. THE PARAMEDICS GAVE HIM AN IV, WAS TAKEN TO THE HOSPITAL. THEY KEPT HIM THERE FOR 3 HOURS, UNTIL HIS BLOOD GLUCOSE WAS 260MG/DL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8287759 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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