STATSTRIP 1.86Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00385480547901), received between Apr 20, 2017 and Sep 25, 2026 — classified as 1 death, 32 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (12 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026High Test Results

  A number of glucose tests were performed on a newborn patient. The Nova StatStrip values obtained were consistently higher than those obtained using other test methods.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897042 ↗
• MalfunctionSep 25, 2026High Test Results

  A number of glucose tests were performed on a newborn patient. The Nova StatStrip values obtained were consistently higher than those obtained using other test methods.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896787 ↗
• MalfunctionSep 25, 2026High Test Results

  A number of glucose tests were performed on a newborn patient. The Nova StatStrip values obtained were consistently higher than those obtained using other test methods.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896640 ↗
• MalfunctionFeb 11, 2026Communication or Transmission Problem

  CUSTOMER IS REPORTING THAT THEY'RE SEEING DELAYS IN RESULTS BEING SENT FROM THIER NOVA STATSTRIP 1.86 CONNECTIVITY METERS TO THEIR QML MIDDLEWARE. ALTHOUGH THERE WERE NO DIRECT ALLEGATIONS OF DELAYS IN TREATMENT DUE TO THIS ISSUE, THE POTENTIAL FOR SUCH DELAYS EXISTS FOR ISSUES OF THIS NATURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316751 ↗
• MalfunctionJun 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  POINT OF CARE IS REPORTING THAT A METER WAS USED AND RECEIVED A RESULT OF IN THE 50'S. THE PATIENT WAS THEN TREATED WITH A TYPE OF JELLY MEANT TO BRING THEIR BLOOD SUGARS UP. THE CUSTOMER RAN A TEST, AN INDETRMINATE TIME LATER, AND THEN RECEIVED A RESULT IN THE 300'S. ANOTHER INDETERMINATE TIME LATER, THE FLOOR STAFF USED A DIFFERENT METER AND AGAIN RECEIVED A RESULT IN THE 50'S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205965 ↗
• MalfunctionJun 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCREPANT GLUCOSE RESULTS ON A PATIENT USING A NOVA STATSTRIP GLUCOSE METER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194102 ↗
• MalfunctionMay 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  "WHILE USING A GLUCOMETER ON PEDIATRIC PATIENTS, THREE CONSECUTIVE READINGS SHOWED RESULTS OF >600 MG/DL FROM DIFFERENT TWO PATIENTS. HOWEVER, THE GLUCOMETER PASSED QUALITY CONTROL (QC) CHECKS EARLIER THAT DAY. SUSPECTING AN ABNORMALITY, THE NURSE REPEATED THE TESTS USING A DIFFERENT VIAL OF TEST STRIPS, AND THE >600 READINGS DID NOT RECUR. HOWEVER, SINCE >600 REPORT HAD ALREADY BEEN REPORTED, BLOOD SAMPLES WAS WITHDRAWN AND SENT TO THE LABORATORY FOR CONFIRMATION, DATA WAS 55 MG/DL. THE NURSE THEN PROVIDED THE ORIGINAL VIAL OF TEST STRIPS TO THE LABORATORY, BUT WHEN TESTED QC USING THE LAB'S GLUCOMETER, THE RESULT COULD NOT PRODUCE AND SHOWED ERROR (BAD SAMPLE OR REPLACE STRIP). THE LABORATORY REPORTED THAT A FEW DAYS EARLIER, ANOTHER UNIT HAD ALSO ENCOUNTERED >600 READINGS DURING QC CHECKS WITH A DIFFERENT VIAL FROM THE SAME BATCH, AND HAD DISCARDED THAT VIAL. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046922 ↗
• MalfunctionJan 23, 2024

  BLOOD GLUCOSE ON PATIENT AND THE GLUCOMETER DISPLAY WENT INTO BLUE SCREEN. NO BLOOD SUGAR READING NOTED. PATIENT WAS PRICKED AND BLOOD WAS RETRIEVED, AND THUS WE NEED TO RE-PRICK THE PATIENT. ENDOSCOPY TEAM HAD BEEN USING THIS SPECIFIC GLUCOMETER AND THE NUMBER AT THE BACK OF THE GLUCOMETER IS #54790. GLUCOSE LEVEL WAS COLLECTED AND RESULTED WITH A DIFFERENT GLUCOMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562797 ↗
• DeathOct 20, 2023Low Test Results; Low Test Results

  "THE PATIENT GLUCOSE TESTED AS 12 MG/DL AT 11:33. AFTER GIVING THE VITAGEN (GLUCOSE), A VENOUS SAMPLE WAS DRAWN AND RUN ON THE CLINICAL ANALYZER. THE RESULT WAS TESTED AS 881 MG/DL ON CLINICAL ANALYZER (11:59-12:32). WHILE THE RESULTS STILL KEEPS LOW AS 13 MG/DL ON STATSTRIP GLUCOSE (TEST TIME: 12:14). THE METER REPORTS DIFFERENTLY COMPARING TO THE LAB SYSTEM."

  Patient problems: Hyperglycemia; Peripheral Edema

  MAUDE report 17980167 ↗
• MalfunctionFeb 22, 2023No Apparent Adverse Event; No Apparent Adverse Event

  69 YEAR OLD MALE IN CRITICAL CARE WAS GIVEN 2 AMPS OF DEXTROSE BASED ON CAPILLARY GLUCOSE RESULTS OBTAINED ON THE STATSTRIP GLUCOSE HOSPITAL METER SYSTEM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16420057 ↗
• MalfunctionFeb 23, 2022Imprecise or Erratic Results; Imprecise or Erratic Results

  THE CUSTOMER INDICATED THAT THEIR STATSTRIP WIRELESS METER, SERIAL NUMBER: (B)(4). GLUCOSE RESULT THAT WAS HIGH COMPARED TO THE READINGS REPORTED FROM ANOTHER METER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13587682 ↗
• MalfunctionNov 11, 2021Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THAT THERE WAS A BAR CODE SCANNING ERROR ON A PATIENT'S IDENTIFICATION NUMBER WHILE USING A STAT STRIP (1.86) METER. THE INCIDENT OCCURRED ON (B)(6) 2021. THE CUSTOMER STATED THAT THEY WERE UNAWARE OF ANY POTENTIAL PATIENT HARM FROM THE BARCODE MISREAD AND WILL NOT BE RETURNING THE METER AS IT IS CURRENTLY IN USE AT THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12796602 ↗
• MalfunctionNov 7, 2021Imprecise or Erratic Results; Imprecise or Erratic Results

  THE CUSTOMER INDICATED THAT THEIR STATSTRIP WIRELESS METER, SERIAL NUMBER: (B)(6), REPORTED GLUCOSE RESULTS THAT DID NOT MATCH GLUCOSE RESULTS FROM ABL825 BLOOD GAS. PATIENT WAS BORN AT 22 WEEKS AND 2 DAYS GESTATION AND WAS RECEIVING CONTINUOUS IV NUTRITION (TPN, DEXTROSE, LIPIDS). NURSING QUESTIONED THE RESULTS BASED ON OTHER LAB VALUES; SPECIFICALLY THE GLUCOSE FROM THE ABL. PATIENT WAS ALREADY IN CRITICAL CONDITION WITH SEPSIS AND PASSED ON (B)(6), HOWEVER, THE METER RESULT WAS NOT USED IN ANY CARE DECISIONS AS PER THE CUSTOMER.

  Patient problems: Sepsis

  MAUDE report 12759923 ↗
• MalfunctionSep 28, 2021Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THERE WAS A BAR CODE SCANNING ERROR ON A PATIENT'S IDENTIFICATION NUMBER WHILE USING A STAT STRIP (1.86) METER. THE INCIDENT OCCURRED ON SEPTEMBER 15, 2021. THE CUSTOMER STATES THEY ARE UNAWARE OF ANY POTENTIAL PATIENT HARM FROM THE BARCODE MISREAD AND WILL NOT BE RETURNING THE METER AS IT IS CURRENTLY IN USE AT THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12542019 ↗
• MalfunctionAug 20, 2021Sparking; Sparking

  THE CUSTOMER REPORTED SEEING SPARKS COME FROM A STATSTRIP 1.86 METER WITH SERIAL NUMBER (B)(4) ON JULY 23RD. THE BATTERY COMPARTMENT HAD THE BATTERY COVER IN PLACE AND THE SPARKS WERE STILL VISIBLE. THE SCREEN WAS FLASHING ON THE METER, SOMETHING IT IS NOT INTENDED TO DO. THE METER WAS TAKEN OUT OF SERVICE AND NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12349570 ↗
• MalfunctionMay 5, 2021Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THAT THE STATSTRIP WIRELESS METER (1.86) S/N: (B)(4) HAD BEEN SITTING IN THE DOCKING STATION S/N:(B)(4), WHILE STILL WORKING, IT SMELLS LIKE SMOKE. THE CUSTOMER DISCONTINUE USE OF THE METER. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION REPORTED. THE METER AND DOCKING STATION WAS RETURNED FOR EVALUATION. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778717 ↗
• MalfunctionMar 18, 2021Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED AN INCORRECT PATIENT ACCOUNT NUMBER SHOWN WHEN SCANNED BY THE STATSTRIP (1.86) METER. THIS OCCURRED ON (B)(6) 2021. THE METER READ A 4 AS A 6 ERRONEOUSLY. THE CUSTOMER STATES THEY ARE UNAWARE OF ANY PATIENT HARM FROM THE BARCODE MISREAD AND WILL NOT BE RETURNING THE METER AS IT IS CURRENTLY IN USE AT THE FACILITY.

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

  MAUDE report 11519966 ↗
• MalfunctionMar 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO THE FDA (UF/IMPORTER REPORT #: (B)(4)) THAT ON (B)(6) 2021 A PATIENT HAD A BEDSIDE GLUCOSE TEST DONE. THE BLOOD WAS COLLECTED BY THE PHLEBOTOMIST AND RAN ON THE UNITS GLUCOMETER AT THE BEDSIDE. THE RESULTS WAS 54. HOWEVER, THE BLOOD WAS COLLECTED AND TESTED IN THE LAB WAS 68. THE CUSTOMER CONCERN IS THAT NEONATAL BLOOD SUGARS THAT ARE DIFFERENT CAN REQUIRE TREATMENT BASED ON THE NUMBERS. ACCORDING TO THE CUSTOMER, THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE INCIDENT.

  Patient problems: Hypoglycemia

  MAUDE report 11507891 ↗
• MalfunctionMar 17, 2021Non Reproducible Results; Imprecise or Erratic Results; Non Reproducible Results; Imprecise or Erratic Results

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING DISCREPANT GLUCOSE RESULTS USING A STATSTRIP 1.86 HOSPITAL METER, SERIAL NO. (B)(4) AND GLUCOSE TEST STRIPS, LOT NO. 0319163249. IT WAS REPORTED THAT GLUCOSE DISCREPANCIES FOR HEELSTICK TEST WERE OBSERVED FOR A NEONATE PATIENT. NO INAPPROPRIATE TREATMENT WAS STARTED AND THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11504490 ↗
• MalfunctionMar 8, 2021Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED AN INCORRECT PATIENT ACCOUNT NUMBER SHOWN WHEN SCANNED BY THE STATSTRIP (1.86) METER. THIS OCCURRED ON (B)(6) 2021. UNFORTUNATELY, THE FACILITY COULD NOT DETERMINE WHICH PATIENT CHART STICKER WAS USED WHEN THIS INCIDENT OCCURRED. THE CUSTOMER STATES THEY ARE UNAWARE OF ANY POTENTIAL PATIENT HARM FROM THE BARCODE MISREAD AND WILL NOT BE RETURNING THE METER AS IT IS CURRENTLY IN USE AT THE FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 11437408 ↗
• MalfunctionMar 3, 2021Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THAT THEY HAD A PATIENT ACCOUNT NUMBER SHOW THE WRONG NUMBER WHEN SCANNED BY THE STATSTRIP (1.86) METER. THIS OCCURRED ON (B)(6) ALL THE SAME PATIENT THAT WAS DISCHARGED BACK ON (B)(6) 2020. IT WAS ALSO STATED THAT THIS HAPPENED USING 2 DIFFERENT METERS BUT WITHIN THE SAME UNIT AREA. UNFORTUNATELY WHEN THIS WAS DISCOVERED IT WAS ON (B)(6) AND OPERATORS ON THE FLOOR COULD NOT DETERMINE WHICH PATIENT ARMBAND WAS USED WHEN THIS INCIDENT OCCURRED. THE FACILITY PROVIDED FOUR METER SERIAL NUMBERS: (B)(4) THAT WERE GIVEN AS POTENTIAL METERS THAT WERE LOCATED ON THE FLOOR. THE CUSTOMER STATES THAT THEY ARE UNAWARE OF ANY POTENTIAL PATIENT HARM FROM THE BARCODE MISREAD AND WILL NOT BE RETURNING THE METERS AS THEY ARE CURRENTLY IN USE AT THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11406135 ↗
• MalfunctionDec 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THERE WAS A BARCODE MISREAD ON A STATSTRIP METER. THE FACILITY REPORTED THAT THE METER SCANNED A PATIENT BARCODE IN THE EMERGENCY DEPARTMENT, HOWEVER WAS UNSUCCESSFUL IN OBTAINING ACCURATE DETAILS OF THE DISCREPANT READ. THE CUSTOMER STATED THAT THE INFORMATION WAS DETAINED IN THEIR SYSTEM AND THEY WERE UNABLE TO DETERMINE WHO THE PATIENT WAS AND UNABLE TO OBTAIN THE ARMBAND. THE FACILITY IS CONTINUING TO UTILIZE THE METER, THEREFORE; NO SAMPLE WAS RETURNED TO NOVA FOR EVALUATION. THERE WAS NO REPORTED PATIENT HARM OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10985011 ↗
• MalfunctionJul 24, 2020Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020 A CUSTOMER REPORTED TO NOVA BIOMEDICAL THAT THERE WAS A BARCODE MISREAD WHILE SCANNING A 1D BARCODE WITH A STATSTRIP WIRELESS METER (1.86) S/N: (B)(4). PATIENT'S BARCODE NUMBER IS (B)(6) BUT IT WAS SCANNED AS (B)(6) BY THE METER. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10321090 ↗
• MalfunctionApr 27, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THERE WAS A BARCODE MISREAD ON A STATSTRIP WIRELESS METER (1.86) S/N: (B)(4). THE USER FACILITY REPORTED THAT THE METER SCANNED PATIENT BARCODE # (B)(6) AS (B)(6). THE FACILITY IS CONTINUING TO UTILIZE THE METER, THEREFORE; NO SAMPLE WILL BE RETURNED FOR EVALUATION. THERE WAS NO REPORTED PATIENT HARM OR INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10001691 ↗
• MalfunctionApr 9, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  UPON PATIENT'S ARRIVAL TO EMERGENCY DEPARTMENT (ED), THE PATIENT'S BLOOD GLUCOSE (BG) LEVEL WAS CHECKED USING GLUCOMETER. THE BLOOD GLUCOSE ON GLUCOMETER READ 47. PATIENT WAS TREATED WITH D50 PER EMERGENCY DEPT PROVIDER, BY PRIMARY RN 10 MINUTES LATER. A COMPREHENSIVE METABOLIC PANEL COLLECTED IMMEDIATELY AFTER BLOOD GLUCOSE (BG) WAS CHECKED WITH GLUCOMETER, RESULTED AND SHOWED GLUCOSE TO BE 75. TO CONFIRM, 2 HOURS LATER GLUCOSE CONFIRMATORY DONE WITHIN 5 MINUTES OF BLOOD GLUCOSE FINGERSTICK TO SHOW GLUCOSE OF 85. GLUCOMETER SHOWED 60 FROM FINGERSTICK.

  Patient problems: No Information

  MAUDE report 9943278 ↗