StatStrip 63685Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00385480636858), received between Apr 29, 2025 and Sep 23, 2026 — classified as 3 deaths, 30 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (18 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K232075); 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.

Recalls naming this device

1. Jul 29, 2026Open, Classified

   A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.

   Z-3128-2026 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Computer Software Problem

  Consumer reported results going to incorrect chart.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867194 ↗
• MalfunctionSep 23, 2026Computer Software Problem

  Consumer reported results went to the wrong patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867193 ↗
• MalfunctionSep 23, 2026Computer Software Problem

  Consumer reported the wrong account number going to a different patient after scanning and running the test.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867192 ↗
• MalfunctionSep 23, 2026Computer Software Problem

  Consumer reported results going to incorrect chart.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867191 ↗
• MalfunctionSep 23, 2026Computer Software Problem

  Consumer reported results going into incorrect chart.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867190 ↗
• MalfunctionSep 23, 2026Computer Software Problem

  The consumer reported patient results transmitted to another chart.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867189 ↗
• MalfunctionSep 23, 2026Computer Software Problem

  Consumer reported results going to incorrect chart.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867188 ↗
• MalfunctionSep 23, 2026Computer Software Problem

  Consumer reported an incident of the wrong account number going to a different patient after scanning and running the test.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867187 ↗
• MalfunctionSep 22, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859368 ↗
• MalfunctionSep 22, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859070 ↗
• MalfunctionSep 22, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858156 ↗
• MalfunctionSep 22, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857458 ↗
• MalfunctionSep 22, 2026Computer Software Problem

  Per vustomer: "PCT utilized the Nova STAT STRIP glucometer 2.0. Scanned patient A for a finger stick draw but the results went into the prior tested patients chart. When the user realized it was not in the patients chart she repeated the test and that result was correctly entered into the patients chart. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855569 ↗
• MalfunctionSep 22, 2026Computer Software Problem

  Per customer: "Glucose checked was done at 3:22 with glucometer number 3A3, result were downloaded on a different patient. Correct patients armband was scanned and still result were downloaded to the other chart. Glucometer was held at HUC desk for follow up. Error was caught on time and no one was treated or patient was harmed. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853876 ↗
• DeathAug 31, 2026Output Problem

  Glucose test performed on 3 different meters and different vials of strips. All gave "Bad Sample" error.

  Patient problems: Insufficient Information

  MAUDE report 50525609 ↗
• DeathAug 31, 2026Output Problem

  Glucose test performed on 3 different meters and different vials of strips. All gave "Bad Sample" error.

  Patient problems: Insufficient Information

  MAUDE report 50525607 ↗
• DeathJul 27, 2026Output Problem

  Glucose test performed on 3 different meters and different vials of strips. All gave "Bad Sample" error.

  Patient problems: Insufficient Information

  MAUDE report 50005856 ↗
• MalfunctionApr 22, 2026Electrical /Electronic Property Problem

  NURSE REPORTED TO CUSTOMER THAT THE DEVICE GOT HOT WHILE IN THE CHARGING DOCK (SINGLE) AND THE SCREEN WENT BLACK. WHEN NURSE TOOK IT OUT OF THE DOCK, METER WAS STILL POWERED ON BUT THE SCREEN REMAIN BLACK. PER CUSTOMER, "EMPLOYEE DROPPED THE METER WHEN PICKED UP OFF OF SINGLE DOCKING STATION DUE TO IT BEING VERY HOT - STARTLING HER. PATIENT TESTING WAS DELAYED DUE TO NOT KNOWING WHAT TROUBLESHOOTING STEPS TO TAKE TO RESOLVE OVERHEATING AND HAD TO GRAB A LOANER ON THE OTHER SIDE OF THE ER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953027 ↗
• MalfunctionApr 17, 2026Computer Software Problem

  STATSTRIP GEN 2 METER SENT A PATIENT RESULT TO THE WRONG PATIENTS CHART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911977 ↗
• MalfunctionJan 30, 2026Computer Software Problem

  STATSTRIP METER WAS SENDING THE SAME RESULT OVER AND OVER TO CUSTOMERS CONNECTIVITY SOFTWARE (QML) WHICH BLOCKED THE REST OF THEIR RESULTS FROM TRANSMITTING TO THE PATIENTS CHART. ALTHOUGH THERE WAS NO DIRECT ALLEGATION OF THIS ISSUE LEADING TO A DELAY IN TREATMENT, THIS COULD HAVE POTENTIALLY LEAD TO DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223623 ↗
• MalfunctionJan 2, 2026Computer Software Problem

  METER ACCEPTED A PATIENT RESULT AND SHOWS ON THE METER THAT THE RESULT WAS INDEED ACCEPTED. INSIDE OF NOVANET (METER SOFTWARE) AND QML (MIDDLEWARE) THIS RESULT SHOWS THAT IT WAS NOT ACCEPTED ON THE METER. THUS PREVENTING THE RESULT FROM GOING TO THE PATIENTS CHART. THIS COULD HAVE LED TO POTENTIAL DELAYS IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23949611 ↗
• MalfunctionDec 19, 2025Computer Software Problem; Computer Software Problem

  PER CUSTOMER: "1. FIRMWARE 1.1.14.7 WAS INSTALLED ON A SMALL COHORT OF NOVA METERS AS DIRECTED BY NOVA TO TEST PROJECTED METER ENHANCEMENTS TO IMPROVE KNOWN ISSUES WE WERE EXPERIENCING. 2. THE METERS WERE DISTRIBUTED TO OUR TEST UNIT LOCATION ON (B)(6) 2025 AT 8:00 AM. 3. ALL PATIENT RESULTS STOPPED INTERFACING TO THE ELECTRONIC HEALTH RECORD AT 8:12 AM BUT THIS INTERRUPTION WAS NOT NOTICED UNTIL 10:35AM. 4. VCUMC INTERNAL IT TROUBLESHOOTING PROCESS WAS INITIATED WHICH CONSISTED OF REBOOTING THE NOVANET SERVERS WHICH IS A PROCESS THAT HAS PREVIOUSLY RESOLVED INTERFACE CONNECTIVITY ISSUES. 5. NOVANET REBOOTED TWICE AND FAILED TO RESTORE CONNECTIVITY. A SYSTEM WIDE MAJOR IT INCIDENT WAS DECLARED DUE TO INTERFACE DOWNTIME. 6. NOVA TECHNICAL SUPPORT WAS CALLED AROUND 11AM AND NOTIFIED OF ISSUE. WE WERE NOTIFIED THAT TECHNICAL SUPPORT WAS NOT AVAILABLE AND THEY WOULD CALL US BACK. 7. AROUND 12:40PM, WAS ABLE TO GET ON A CALL WITH NOVA TO TROUBLESHOOT WHY RESULTS WERE NOT CROSSING TO THE EHR AND IT WAS NOTED THE 1.1.14.7 FIRMWARE METERS WERE SENDING AN INCORRECT LETTER "P" PREVENTING RESULTS FROM INTERFACING TO THE EHR. 8. WE WERE ADVISED TO STOP USING THE 1.1.14.7 METERS IMMEDIATELY AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854676 ↗
• MalfunctionJun 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  "NUMEROUS COMPLAINTS FROM NEWBORN NURSERY REGARDING COMPARISON OF NOVA GLUCOSE METER RESULTS WITH MAIN LABORATORY RESULTS. NOVA CONSISTENTLY TESTING LOWER LEADING TO TREATMENT OF NEWBORN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22188074 ↗
• MalfunctionJun 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  "NUMEROUS COMPLAINTS FROM NEWBORN NURSERY REGARDING COMPARISON OF NOVA GLUCOSE METER RESULTS WITH MAIN LABORATORY RESULTS. NOVA CONSISTENTLY TESTING LOWER LEADING TO TREATMENT OF NEWBORN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187148 ↗
• MalfunctionJun 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  "NUMEROUS COMPLAINTS FROM NEWBORN NURSERY REGARDING COMPARISON OF NOVA GLUCOSE METER RESULTS WITH MAIN LABORATORY RESULTS. NOVA CONSISTENTLY TESTING LOWER LEADING TO TREATMENT OF NEWBORN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186940 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K232075. One submission often covers many models, so check the product and lot details in each record.

• Z-3129-2026 · Jul 29, 2026 · Open, Classified
  StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
• Z-0681-2025 · Nov 20, 2024 · Open, Classified
  StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.