StatStrip 1.0 (REF 43773)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00385480437738), received between Feb 15, 2017 and Feb 16, 2017 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2017Incorrect Or Inadequate Test Results

  RECEIVED USER-FACILITY REPORT # (B)(4): ROUTINE POC BLOOD GLUCOSE RESULT OF "HI". BLOOD SUGAR RECHECKED WITH DIFFERENT GLUCOMETER WITH READING OF 151.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6335934 ↗
• MalfunctionFeb 15, 2017Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  USER-FACILITY MEDWATCH REPORT # (B)(4) RECEIVED "CHECKED PATIENT GLUCOSE PRIOR TO DINNER AND READING WAS 481. PATIENT HAS NOT BEEN HAVING HIGH GLUCOSE. RECHECKED THE GLUCOSE AFTER 1 MINUTE AND READING WAS 280 WITH SAME GLUCOMETER WITHOUT ANY INTERVENTIONS. GLUCOMETER TAKEN OUT OF SERVICE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6333065 ↗