StatStrip GLU Test StripRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10385480422144), received between Nov 15, 2018 and Jun 1, 2026 — classified as 2 deaths, 27 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• DeathJun 1, 2026Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information

  RESULTS ON A PATIENT DO NOT MATCH MAIN ANALYZER. PATIENT ARRIVED AT (B)(6) EMERGENCY DEPARTMENT WITH ACUTE RESPIRATORY FAILURE. PATIENT PASSED AWAY.

  Patient problems: Hyperglycemia; Insufficient Information

  MAUDE report 25355074 ↗
• MalfunctionDec 12, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE CONSUMER REPORTED TO NOVA BIOMEDICAL THAT WHEN RUNNING A GLUCOSE TEST ON A 16-YEAR-OLD PATIENT, A SIGNIFICANT DISCREPANCY WAS OBSERVED WHEN COMPARING GLUCOSE RESULTS. THE PATIENT WAS NOT TREATED BASED OFF THESE RESULTS AND NO ADVERSE EVENTS HAVE BEEN REPORTED. AT THIS TIME, HANDLING OF THE TEST STRIPS IS UNKNOWN. THE CAPILLARY SAMPLE WAS TAKEN FROM THE FINGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789703 ↗
• DeathNov 11, 2025Low Test Results; Low Test Results

  THE COMPLAINANT REPORTED SIGNIFICANT DISCREPANCIES BETWEEN LAB VALUES AND THE STATSTRIP XPRESS MEASUREMENT VALUES. UPON ARRIVAL, THE PATIENT WAS SAID TO BE IN AN "UNCONSCIOUS" AND HYPOTHERMIC STATE, BODY TEMPERATURE MEASUREMENT WAS NOT POSSIBLE. THE COMPLAINANT RECOGNIZES THAT THERE IS NO CAUSAL RELATIONSHIP BETWEEN PATIENT'S EXPIRATION AND THE METER RESULTS. TREATMENT FOR PATIENT WAS DELAYED UNTIL LABORATORY REFERENCE VALUE BECAME AVAILABLE. IT WAS REPORTED THAT THE PATIENT EXPIRED SOMETIME LATER.

  Patient problems: Decreased Appetite; Hypoglycemia; Hypothermia

  MAUDE report 23525794 ↗
• MalfunctionJun 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  "GLUCOMETERS USING THESE STRIPS WERE READING LESS THAN 20 BUT A DIFFERENT BOTTLE OF STRIPS READ 142."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203947 ↗
• MalfunctionJan 2, 2024Low Test Results; Low Test Results

  RECEIPT OF MEDWATCH REPORT: 2400040000-2023-8038 PATIENT BLOOD GLUCOSE AT 1616 WAS 64. HYPOGLYCEMIA PROTOCOL NOT ORDERED; TEAM PAGED REQUESTING PROTOCOL BE ORDERED. PATIENT REFUSING PO INTAKE, 25MLS OF D50 GIVEN PER PROTOCOL. RECHECK AFTER 15 MIN WAS 24. PATIENT COMPLETELY ALERT, EVEN AGITATED DURING CARES. TEAM PAGED. SECOND DOSE OF D50 GIVEN. CONTINUOUS D5NS INITIATED PER NEW ORDER. BG (BLOOD GLUCOSE) CONTINUED TO DROP WITH RECHECKS, GLUCOMETER SHOWED A BG OF 27 AND THEN 11. ATTEMPTED AGAIN WITH NEW TEST STRIPS, BG WAS 99.

  Patient problems: Hypoglycemia

  MAUDE report 18429385 ↗
• MalfunctionApr 19, 2022Imprecise or Erratic Results; Imprecise or Erratic Results

  THE CUSTOMER INDICATED THAT THEIR STAT STRIP METER, SERIAL NUMBER: (B)(4) GAVE A LOWER RESULT COMPARED TO ANOTHER METER. PATIENT WAS TRANSFERRED TO PEDIATRICS AND TESTED AGAIN. CUSTOMER CONFIRMED THAT THE STAT STRIP METER WAS PASSING QC. USING TEST STRIP LOT 0320153249 PN 54515. IT WAS INDICATED THAT THERE WAS NO ADVERSE EVENT DUE TO THE METER.

  Patient problems: Insufficient Information

  MAUDE report 14147884 ↗
• MalfunctionApr 19, 2022Failure to Sense; Failure to Sense

  CUSTOMER INDICATED THAT WHEN MEASURING THE GLUCOSE FOR THE PATIENT, THE METER COULD NOT PROVIDE A RESULT AFTER THE SAMPLE WAS APPLIED. THE METER DID RECOGNIZE WHEN THE STRIP WAS INSERTED. SAMPLE WAS APPLIED TO THE STRIP AND THE METER DID NOT PROGRESS TO THE ANALYZING COUNTDOWN. ANOTHER STRIP WAS USED AND WAS ABLE TO OBTAIN A RESULT. IT WAS NOT INDICATED WHETHER THE NEW STRIP WAS FROM A DIFFERENT LOT OR SAME LOT. CUSTOMER WAS USING TEST STRIP LOT 0320153249. THERE WAS NO ADVERSE ACTION INDICATED DUE TO THE METER.

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

  MAUDE report 14147590 ↗
• MalfunctionApr 11, 2022Failure to Sense; Failure to Sense

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING ANALYSIS OF GLUCOSE RESULTS DURING THE TREATMENT OF A PATIENT WHILE USING AN UNIDENTIFIED NOVA STATSTRIP GLUCOSE METER. THE USER INDICATED THE METER WAS ASKING FOR A SAMPLE TO BE APPLIED TO THE DISPOSABLE TEST STRIP OF LOT 0321102249, BUT IT DID NOT RECOGNIZE WHEN THE SAMPLE WAS APPLIED. THE METER RECOGNIZED THE STRIP WHEN INSERTED BUT DID NOT INITIATE ANALYSIS WHEN THE SAMPLE WAS APPLIED. ANOTHER TEST STRIP WAS IMMEDIATELY USED WHICH PROVIDED A RESULT. NO PATIENT HARM OR ADVERSE TREATMENT DUE TO THE LACK OF RESULTS WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14077892 ↗
• MalfunctionApr 11, 2022Failure to Sense; Failure to Sense

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING ANALYSIS OF GLUCOSE RESULTS DURING THE TREATMENT OF A PATIENT WHILE USING AN UNIDENTIFIED NOVA STATSTRIP GLUCOSE METER. THE USER INDICATED THE METER DID NOT RECOGNIZE THE DISPOSABLE TEST STRIP OF LOT 0321069249 WHEN INSERTED. ANOTHER TEST STRIP FROM THE SAME VIAL WAS USED WHICH ALSO WAS NOT RECOGNIZED BY THE METER. A SECOND VIAL OF TEST STRIPS WAS USED OF AN UNKNOWN LOT AND THE METER RECOGNIZED THESE STRIPS WHEN INSERTED AND PROVIDED A RESULT. NO PATIENT HARM OR ADVERSE TREATMENT DUE TO THE LACK OF RESULTS WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14077827 ↗
• MalfunctionApr 11, 2022Unable to Obtain Readings; Unable to Obtain Readings

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING ANALYSIS OF GLUCOSE RESULTS DURING THE TREATMENT OF A PATIENT WHILE USING AN UNIDENTIFIED NOVA STATSTRIP GLUCOSE METER. THE USER INDICATED THE METER WAS ASKING FOR A SAMPLE TO BE APPLIED TO THE DISPOSABLE TEST STRIP OF LOT 0320070249, ANALYZED THE SAMPLE AND COUNTED DOWN, THEN PRODUCED AN ERROR CODE SAYING "BAD SAMPLE". THIS OCCURRED MULTIPLE TIMES USING DIFFERENT TEST STRIPS. NO PATIENT HARM OR ADVERSE TREATMENT DUE TO THE LACK OF RESULTS WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14077809 ↗
• MalfunctionApr 11, 2022Failure to Sense; Failure to Sense

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING ANALYSIS OF GLUCOSE RESULTS DURING THE TREATMENT OF A PATIENT WHILE USING AN UNIDENTIFIED NOVA STATSTRIP GLUCOSE METER. THE USER INDICATED THE METER WAS ASKING FOR A SAMPLE TO BE APPLIED TO THE DISPOSABLE TEST STRIP OF LOT 0321069249, BUT IT DID NOT RECOGNIZE WHEN THE SAMPLE WAS APPLIED. THE METER RECOGNIZED THE STRIP WHEN INSERTED BUT DID NOT INITIATE ANALYSIS WHEN THE SAMPLE WAS APPLIED. ANOTHER TEST STRIP WAS IMMEDIATELY USED WHICH PROVIDED A RESULT. NO PATIENT HARM OR ADVERSE TREATMENT DUE TO THE LACK OF RESULTS WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14077781 ↗
• MalfunctionApr 11, 2022Failure to Sense; Failure to Sense

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING ANALYSIS OF GLUCOSE RESULTS DURING THE TREATMENT OF A PATIENT WHILE USING AN UNIDENTIFIED NOVA STATSTRIP GLUCOSE METER. THE USER INDICATED THE METER WAS ASKING FOR A SAMPLE TO BE APPLIED TO THE DISPOSABLE TEST STRIP OF LOT 0319231249, BUT IT DID NOT RECOGNIZE WHEN THE SAMPLE WAS APPLIED. THE METER RECOGNIZED THE STRIP WHEN INSERTED BUT DID NOT INITIATE ANALYSIS WHEN THE SAMPLE WAS APPLIED. ANOTHER TEST STRIP WAS IMMEDIATELY USED WHICH PROVIDED A RESULT. NO PATIENT HARM OR ADVERSE TREATMENT DUE TO THE LACK OF RESULTS WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14077734 ↗
• MalfunctionApr 11, 2022Failure to Sense; Failure to Sense

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING ANALYSIS OF GLUCOSE RESULTS DURING THE TREATMENT OF A PATIENT WHILE USING AN UNIDENTIFIED NOVA STATSTRIP GLUCOSE METER. THE USER INDICATED THE METER WAS ASKING FOR A SAMPLE TO BE APPLIED TO THE DISPOSABLE TEST STRIP OF LOT 0320070249, BUT IT DID NOT RECOGNIZE WHEN THE SAMPLE WAS APPLIED. THE SAMPLE WAS CORRECTLY DRAWN FROM THE HEEL OF THE INFANT PATIENT AND THE FIRST BLOOD DROP WAS DISCARDED. THE METER RECOGNIZED THE STRIP WHEN INSERTED BUT DID NOT INITIATE ANALYSIS WHEN THE SAMPLE WAS APPLIED. ANOTHER TEST STRIP WAS IMMEDIATELY USED WHICH PROVIDED A RESULT. NO PATIENT HARM OR ADVERSE TREATMENT DUE TO THE LACK OF RESULTS WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14077715 ↗
• MalfunctionApr 11, 2022Failure to Sense; Failure to Sense

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING ANALYSIS OF GLUCOSE RESULTS DURING THE TREATMENT OF A PATIENT WHILE USING AN UNIDENTIFIED NOVA STATSTRIP GLUCOSE METER. THE USER INDICATED THE METER WAS ASKING FOR A SAMPLE TO BE APPLIED TO THE DISPOSABLE TEST STRIP OF LOT 0319098249, BUT IT DID NOT RECOGNIZE WHEN THE SAMPLE WAS APPLIED. THE METER RECOGNIZED THE STRIPS WHEN INSERTED BUT DID NOT ANALYZE THE SAMPLE WHEN APPLIED. THIS WAS REPEATED WITH ANOTHER TEST STRIP OF THE SAME LOT WHICH RESULTED IN THE SAME ERROR. BECAUSE OF THIS, RESULTS COULD NOT BE OBTAINED AND NO PATIENT HARM OR ADVERSE TREATMENT DUE TO THE LACK OF RESULTS WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14077580 ↗
• MalfunctionMar 24, 2021Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED TO THE FDA THAT ON (B)(6) 2021 THAT ONE LOT OF STATSTRIP TEST STRIPS LOT NUMBER 0320328249 DID NOT WORK. AN ERROR MESSAGE CAME UP ON THE GLUCOMETER. PRODUCT FAILURE FORM COULD NOT BE LOCATED ON SCOUT. DEVICE WAS REMOVED FROM SERVICE.

  Patient problems: Insufficient Information

  MAUDE report 11564756 ↗
• MalfunctionAug 14, 2020Low Readings; Low Readings

  THE CUSTOMER STATED THAT MULTIPLE PATIENTS IN THE NICU HAD FLUCTUATIONS OF LOW GLUCOSE READINGS WHILE USING STATSTRIP GLUCOSE METER V1.86 SERIAL NUMBERS (B)(4) AND (B)(4) UTILIZING STAT STRIP TEST STRIPS LOT# 0319081249. MULTIPLE ATTEMPTS WERE MADE TO RECEIVE SPECIFIC RESULTS AND OR PATIENT SPECIFIC INFORMATION, HOWEVER; NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE FACILITY. THERE IS NO FURTHER INDICATION OF ADDITIONAL TREATMENT AND OR PATIENT HARM RESULTING FROM THE REPORTED LOW GLUCOSE READINGS.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10410542 ↗
• MalfunctionAug 14, 2020Low Readings; Low Readings

  THE CUSTOMER STATED THAT MULTIPLE PATIENTS IN THE NICU HAD FLUCTUATIONS OF LOW GLUCOSE READINGS WHILE USING STATSTRIP GLUCOSE METER V1.86 SERIAL NUMBERS (B)(4) AND (B)(4) UTILIZING STAT STRIP TEST STRIPS LOT# 0319081249. MULTIPLE ATTEMPTS WERE MADE TO RECEIVE SPECIFIC RESULTS AND OR PATIENT SPECIFIC INFORMATION, HOWEVER; NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE FACILITY. THERE IS NO FURTHER INDICATION OF ADDITIONAL TREATMENT AND OR PATIENT HARM RESULTING FROM THE REPORTED LOW GLUCOSE READINGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10410194 ↗
• MalfunctionMay 22, 2020Low Readings; Low Readings

  THE CUSTOMER STATED THAT THE PATIENT IN THE NICU HAD A LOW GLUCOSE READING AND WAS EXPOSED TO ANIMAL MILK PROTEINS AND OR IV FOR TREATMENT. IT WAS ALSO STATED THAT THERE WERE OTHER INCIDENTS OF LOW GLUCOSE READINGS. MULTIPLE ATTEMPTS WERE MADE TO RECEIVE SPECIFIC RESULTS AND OR PATIENT SPECIFIC INFORMATION, HOWEVER; NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE FACILITY. THERE IS NO FURTHER INDICATION OF ADDITIONAL TREATMENT AND OR PATIENT HARM RESULTING FROM THE PROTEIN OR IV PROVIDED TO THIS PATIENT OR ANY OF THE OTHER INCIDENTS MENTIONED.

  Patient problems: Hypoglycemia; No Consequences Or Impact To Patient

  MAUDE report 10083096 ↗
• MalfunctionNov 13, 2019Low Test Results; Low Test Results

  A USER FACILITY REPORTED DISCREPANT GLUCOSE RESULTS FOR A NEONATE PATIENT. THERE WAS NO PATIENT HARM REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9315005 ↗
• MalfunctionAug 15, 2019Incorrect, Inadequate or Imprecise Result or Readings

  (B)(6) 2019: DISCREPANT GLUCOSE PATIENT RESULTS FOR HEELSTICK USING NOVA STATSTRIP HOSPITAL METER WHEN COMPARED TO LAB REFERENCE ANALYZER. NO ADVERSE EVENT REPORTED, PEDIATRICIAN QUESTIONED THE STATSTRIP RESULTS BASED ON LAB REFERENCE ANALYZER RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8898230 ↗
• MalfunctionAug 1, 2019Incorrect, Inadequate or Imprecise Result or Readings

  DISCREPANT GLUCOSE PATIENT RESULTS USING NOVA STATSTRIP XPRESS 2 GLU/KET METER WHEN COMPARED TO LAB REFERENCE ANALYZER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8852439 ↗
• MalfunctionJun 27, 2019Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019: DISCREPANT GLUCOSE PATIENT RESULTS USING NOVA STATSTRIP HOSPITAL METER WHEN COMPARED TO LAB REFERENCE ANALYZER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8740563 ↗
• MalfunctionMay 22, 2019Incorrect, Inadequate or Imprecise Result or Readings

  DISCREPANT GLUCOSE RESULTS USING NOVA STATSTRIP METER COMPARED TO A NON-NOVA METER AND A SECOND NOVA STATSTRIP METER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8631717 ↗
• MalfunctionMay 9, 2019Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019: DISCREPANT GLUCOSE RESULTS FOR NEONATE WHEN COMPARED TO LAB.

  Patient problems: No Information

  MAUDE report 8595382 ↗
• MalfunctionMay 9, 2019Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019: DISCREPANT GLUCOSE RESULTS FOR NEONATE WHEN COMPARED TO LAB.

  Patient problems: No Information

  MAUDE report 8595381 ↗