CareSens N 164301-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885325000115), received between Aug 10, 2017 and Aug 10, 2017 — 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2017High Readings; High Readings

  THE PATIENT TOOK A FASTING BLOOD GLUCOSE TEST IN THE MORNING AS USUAL, AND THE FIRST RESULT WAS 'HI'. DIRECTLY AFTER TOOK A TEST AND THE RESULT WAS 506 MG/DL. IT WAS STILL MUCH HIGHER THAN EXPECTED (EXPECTS BETWEEN 190 MG/DL AND 240 MG/DL) SO SHE CALLED AN AMBULANCE. NO TREATMENT WAS PERFORMED ON HER BETWEEN THE READING TAKEN AT HOME AND THE AMBULANCE ARRIVING 15 MINS LATER. SHE HAD NO SYMPTOMS CONSISTENT WITH THE HIGH READINGS. WHEN THE EMTS TESTED HER WITH THEIR BGM (UNKNOWN BRAND), THE RESULT WAS 211 MG/DL WHICH IS ON PAR WITH HER USUAL READINGS AT THAT TIME. THEY TREATED HER WITH INSULIN AND SHE REMAINED AT HOME. SHE IS TYPE 2 INSULIN DEPENDENT DIABETIC. SHE HAS NO OTHER WAY TO CHECK HER BLOOD SUGAR CURRENTLY. SHE WILL RETURN HER METER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6783883 ↗