STATSTRIP 1.75 (REF 53398)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00385480533980), received between Apr 21, 2017 and May 2, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Patient Data Problem” (7 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025High Test Results; High Test Results

  THE COMPLAINANT REPORTED "CONFLICTING RESULTS BETWEEN 2 GLUCOMETERS AND PATIENT'S DEXCOM. NURSE ALSO SAID THE PATIENT'S DEXCOM WAS "OUT OF WACK" AS WHEN JUICE WAS GIVEN THE DEXCOM READING DID NOT CHANGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953028 ↗
• MalfunctionFeb 10, 2022Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTS THAT A STATSTRIP METER SCANNED A PATIENT ARMBAND INCORRECTLY. WHEN ONE PATIENT WAS SCANNED, A DIFFERENT PATIENT'S DATA APPEARED. AFTER A RESCAN, THE CORRECT PATIENT'S INFORMATION APPEARED SO THE RESPONSIBLE METER'S SERIAL NUMBER WAS NOT TAKEN NOTE OF. THERE WAS NO PATIENT HARM OR INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13505963 ↗
• MalfunctionJan 26, 2022Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTS THAT A STATSTRIP METER SCANNED A PATIENT ARMBAND INCORRECTLY. WHEN ONE PATIENT WAS SCANNED A DIFFERENT PATIENT'S DATA APPEARED. AFTER A RESCAN THE CORRECT PATIENT'S INFORMATION APPEARED SO THE METER'S SERIAL NUMBER WAS NOT TAKEN NOTE OF. THERE WAS NO PATIENT HARM OR INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359388 ↗
• MalfunctionJul 8, 2021Failure to Transmit Record; Failure to Transmit Record

  THE CUSTOMER REPORTED A STATSTRIP GLUCOSE HOSPITAL METER MALFUNCTIONED WHICH REQUIRED HAVING TO USE AN ADDITIONAL METER TO OBTAIN GLUCOSE RESULTS FOR A PATIENT. THE EVENT OCCURRED IN THE PULMONARY CLINIC WHILE ATTEMPTING TO OBTAIN GLUCOSE MEASUREMENTS FOR A RAPID RESPONSE INCIDENT. THERE WAS NO INDICATION OF PATIENT HARM AS A SECOND STATSTRIP GLUCOSE HOSPITAL METER WAS AVAILABLE FOR USE AFTER RUNNING THE REQUIRED QUALITY CONTROL MATERIAL. THE REPORTED STATSTRIP GLUCOSE HOSPITAL METER MALFUNCTIONED BY REQUIRING QUALITY CONTROL MATERIAL TO BE RUN AGAIN, DESPITE HAVING BEEN RUN IN THE LAST 24 HOURS AS REQUIRED, AND BY NOT RECOGNIZING THREE CERTIFIED OPERATORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135760 ↗
• MalfunctionMay 11, 2021Imprecise or Erratic Results; Imprecise or Erratic Results

  THE CUSTOMER REPORTED DISCREPANT PATIENT RESULTS. A TEST WAS RUN ON (B)(6) ON THE STATSTRIP 1.75 METER SN: (B)(4) AND A FLOW ERROR OCCURRED. IT WAS RERUN AND WAS LESS THAN 10, A DRAW WAS DONE AND IT WAS 532. THE PATIENT WAS MOVED TO ANOTHER FLOOR AND TESTED WITH ANOTHER METER AND RECEIVED GOOD RESULTS. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809037 ↗
• MalfunctionMar 17, 2021Patient Data Problem; Patient Data Problem

  A CUSTOMER REPORTED THAT GLUC CONN METERS (1.75) MIS-SCANNING 1D BAR SHOWING INCORRECT PATIENT ID'S. THE ACCOUNT HAS 1 & 2 D BAR CODES ON PATIENTS WRISTS. THERE HAS BEEN NO REPORT OF PATIENT HARM OR ADVERSE EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11507600 ↗
• MalfunctionMar 17, 2021Patient Data Problem; Patient Data Problem

  A CUSTOMER REPORTED THAT GLUC CONN METERS (1.75) MIS-SCANNING 1D BAR SHOWING INCORRECT PATIENT ID'S. THE ACCOUNT HAS 1 & 2 D BAR CODES ON PATIENTS WRISTS. THERE HAS BEEN NO REPORT OF PATIENT HARM OR ADVERSE EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11507527 ↗
• MalfunctionMar 17, 2021Patient Data Problem; Patient Data Problem

  A CUSTOMER REPORTED THAT GLUC CONN METERS (1.75) MIS-SCANNING 1D BAR SHOWING INCORRECT PATIENT ID'S. THE ACCOUNT HAS 1 & 2 D BAR CODES ON PATIENTS WRISTS. THERE HAS BEEN NO REPORT OF PATIENT HARM OR ADVERSE EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11507503 ↗
• MalfunctionMar 17, 2021Patient Data Problem; Patient Data Problem

  A CUSTOMER REPORTED THAT GLUC CONN METERS (1.75) MIS-SCANNING 1D BAR SHOWING INCORRECT PATIENT ID'S. THE ACCOUNT HAS 1 & 2 D BAR CODES ON PATIENTS WRISTS. THERE HAS BEEN NO REPORT OF PATIENT HARM OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11507427 ↗
• MalfunctionMar 17, 2021Patient Data Problem; Patient Data Problem

  A CUSTOMER REPORTED THAT GLUC CONN METERS (1.75) MIS-SCANNING 1D BAR SHOWING INCORRECT PATIENT ID'S. THE ACCOUNT HAS 1 & 2 D BAR CODES ON PATIENTS WRISTS. THERE HAS BEEN NO REPORT OF PATIENT HARM OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11507402 ↗
• MalfunctionDec 22, 2020Melted; Overheating of Device; Smoking; Overheating of Device

  THE CUSTOMER REPORTED THAT THE STATSTRIP WIRELESS METER (1.75) S/N: (B)(4) HAD BEEN SITTING IN THE DOCKING STATION S/N:(B)(4) FOR APPROXIMATELY ONE WEEK. WHEN THE METER WAS REMOVED FROM THE DOCKING STATION, THERE WAS A SMALL PUFF OF BLACK SMOKE, THE PLASTIC CASE WAS SLIGHTLY MELTED AND THE CONNECTION PINS APPEARED RED. THE BATTERY WAS REMOVED AND THE DOCKING STATION UNPLUGGED. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION REPORTED. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11059406 ↗
• MalfunctionApr 21, 2017Insufficient Device Problem Information

  FACILITY CALLED TO REPORT CONCERN REGARDING A PATIENT (BABY) GLUCOSE RESULT. DUE TO THE RESULT THE BABY WAS MOVED TO THE NICU.

  Patient problems: No Code Available

  MAUDE report 6513482 ↗