Nova Max Plus (REF 43435)Recalls & reported problems
Nova Biomedical Corporation · Nova Max Plus Plus Blood Glucose Monitoring System · Class 1
Quick summary
This is a Nova Max Plus blood glucose meter, a home device people use to check their sugar levels. The 28 reports mostly describe the meter giving readings that seemed wrong or did not match other meters, and displays that dropped digits from the result. Users also reported high or low blood sugar readings and, in one case, passing out. There are 28 reports, with no deaths and no injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00385480434355), received between Mar 3, 2017 and Sep 24, 2020 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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
Device problems
- Adverse Event Without Identified Device or Use Problem9
- Insufficient Device Problem Information4
- Incorrect Or Inadequate Test Results3
- High Readings2
- Improper or Incorrect Procedure or Method2
- Incorrect, Inadequate or Imprecise Result or Readings2
- Device Displays Incorrect Message1
- Device Markings/Labelling Problem1
Patient problems
- Hyperglycemia9
- Hypoglycemia7
- No Known Impact Or Consequence To Patient6
- No Consequences Or Impact To Patient3
- Loss of consciousness2
- No Information2
- Sweating2
- Fainting1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2020Imprecision; Imprecision
COMPLAINANT REPORTED THAT SHE IS CONCERNED ABOUT A DISCREPANCY USING HER NOVA MAX PLUS BLOOD GLUCOSE MONITOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10581731 ↗MalfunctionJun 2, 2020Display Difficult to Read; Display Difficult to Read; Device Markings/Labelling Problem
THE CONSUMER CALLED IN REPORTING HER METER IS MISSING DIGITS. THE CONSUMER STATED THE FIRST DIGIT OF THE RESULTS IS MISSING AND ALL FOUR DIGITS OF THE YEAR ARE MISSING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10111588 ↗MalfunctionMar 24, 2020Low Readings
COMPLAINANT REPORTED A 'LOW' BLOOD GLUCOSE READING. DID NOT TREAT BASED ON RESULT(S) OBTAINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9871968 ↗MalfunctionDec 24, 2019No Apparent Adverse Event; High Test Results; No Apparent Adverse Event
COMPLAINANT STATED HE IS NOT TESTING CONSISTENTLY DUE TO HIS HIGH BLOOD GLUCOSE READINGS. HE STATED THAT ON (B)(6) 2019 HIS HCP CHANGED HIS INSULIN TYPE AND INCREASED THE DOSE. ON THIS DAY HE STATED HE "PASSED OUT" FOR A FEW MINUTES. AFTER PASSING OUT, THE COMPLAINANT "GOT UP, ATE SOMETHING AND STARTED WATCHING TV". HE REPORTS HE CONTACTED HIS HCP IN REGARD TO THE ISSUE.
Patient problems: Fainting; No Consequences Or Impact To Patient
MAUDE report 9516333 ↗MalfunctionOct 23, 2019No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem
THE COMPLAINANT REPORTED THE METER DISPLAY IS MISSING THE LAST DIGIT FROM HIS TEST RESULT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9226055 ↗MalfunctionJun 18, 2019High Readings
COMPLAINANT REPORTS THAT HE TOOK HIMSELF TO THE HOSPITAL ER BECAUSE HE WAS CONCERNED WITH HIGH BLOOD GLUCOSE READINGS.
Patient problems: Hyperglycemia
MAUDE report 8708623 ↗MalfunctionMar 8, 2019Device Displays Incorrect Message
COMPLAINANT STATED HIS METER SCREEN ONLY DISPLAYS 2 DIGITS OF HIS BLOOD GLUCOSE READING (1ST AND 2ND DIGITS ONLY).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8404941 ↗MalfunctionJan 29, 2019Incorrect, Inadequate or Imprecise Result or Readings
COMPLAINANT WAS CONCERNED ABOUT THE DIFFERENCE IN HER BG READINGS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8286062 ↗MalfunctionOct 22, 2018Adverse Event Without Identified Device or Use Problem
THE COMPLAINANT STATED THAT "BECAUSE OF HER 209MG/DL READING SHE TOOK AN EXTRA DOSE OF GENEVA ALONG WITH NORMAL PILL DOSES". SHE THEN REPORTED THAT SHE WENT FOOD SHOPPING AND FELT "LOW" SHE ATE A CHOCOLATE CANDY BAR AND FELT BETTER.
Patient problems: Hyperglycemia; Hypoglycemia; Overdose
MAUDE report 7991849 ↗MalfunctionOct 22, 2018Improper or Incorrect Procedure or Method; High Readings
A NURSE CALLED IN ON BEHALF OF COMPLAINANT REPORTING BLOOD GLUCOSE READINGS OF 'HI' (METER WILL DISPLAY HI WHEN GLUCOSE SAMPLE VALUE IS ABOVE 600MG/DL). AT 2:40AM COMPLAINANT STATED SHE WOKE UP BECAUSE SHE "WAS FEELING COLD, SWEATY AND SHAKY" SHE THEN DRANK SOME ORANGE JUICE DUE TO HER SYMPTOMS AND WENT BACK TO BED.
Patient problems: Hypothermia; Shaking/Tremors; Sweating
MAUDE report 7991459 ↗MalfunctionOct 4, 2018Adverse Event Without Identified Device or Use Problem
COMPLIANANT'S GRANDMOTHER CALLED INTO CUSTOMER CARE CONCERNED ABOUT THE LOW BLOOD GLUCOSE RESULTS OBTAINED WHEN SHE PERFORMED BACK TO BACK TESTS.
Patient problems: Hypoglycemia
MAUDE report 7933351 ↗MalfunctionApr 26, 2018Incorrect Or Inadequate Test Results
COMPLAINANT CALLED INTO CUSTOMER SUPPORT REPORTING INACCURATE READINGS.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 7464581 ↗MalfunctionApr 13, 2018Adverse Event Without Identified Device or Use Problem
COMPLAINANT'S DAUGHTER CALLED IN REPORTING AN INCIDENT ON (B)(6) 2018 WHERE HER MOTHER "...EXPERIENCED A 'HYPOGLYCEMIC EVENT' AND THE EMT'S WERE CALLED TO THE HOUSE..."
Patient problems: Hypoglycemia
MAUDE report 7428260 ↗MalfunctionApr 6, 2018Incorrect Or Inadequate Test Results
COMPLAINANT CALLED IN CONCERNED THAT HIS 2 NOVA MAX PLUS METERS ARE READING DIFFERENTLY. BACK UP METER (B)(4) WITH TEST STRIPS 1020916267 PERFORM AS INTENDED. METER (B)(4) AND TEST STRIPS FROM THE SAME VIAL 1020916267
Patient problems: No Information
MAUDE report 7402565 ↗MalfunctionDec 15, 2017Improper or Incorrect Procedure or Method
COMPLAINANT CALLED INTO CUSTOMER CARE TO EXPRESS HER CONCERNS ABOUT HER READINGS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7121849 ↗MalfunctionNov 29, 2017Insufficient Device Problem Information
THE COMPLAINANT CALLED INTO CUSTOMER CARE (B)(6) 2017 REPORTING A HIGH BLOOD GLUCOSE READING IN (B)(6) OF 2017.
Patient problems: Hyperglycemia
MAUDE report 7068169 ↗MalfunctionNov 15, 2017Image Display Error/Artifact
THE COMPLAINANT CALLED INTO NOVA BIOMEDICAL REPORTING, "SHE ONLY SEES TWO NUMBERS INSTEAD OF THREE WHEN SHE GETS HER BLOOD GLUCOSE RESULT ON THE METER'S DISPLAY"
Patient problems: No Information
MAUDE report 7032460 ↗MalfunctionSep 29, 2017Insufficient Device Problem Information
COMPLAINANT STATED SHE WENT TO THE ER ON SUNDAY ((B)(6) 2017) "BECAUSE HER METER GAVE HER A HIGH READING SHE WAS NOT COMFORTABLE WITH."
Patient problems: Hyperglycemia
MAUDE report 6905083 ↗MalfunctionAug 7, 2017Adverse Event Without Identified Device or Use Problem
THE COMPLIANANT EXPERIENCED 'NIGHT SWEATS' AFTER ADMINISTERING ADDTIONAL INSULIN.
Patient problems: Sweating
MAUDE report 6770615 ↗MalfunctionJun 27, 2017Insufficient Device Problem Information
COMPLAINANT CALLED INTO CUSTOMER CARE REPORTING "...A HYPOGLYCEMIC INCIDENT..." WHERE HE PASSED OUT AND REQUIRED MEDICAL INTERVENTION.
Patient problems: Hypoglycemia; Loss of consciousness
MAUDE report 6670780 ↗MalfunctionMay 24, 2017Adverse Event Without Identified Device or Use Problem
COMPLAINANT CALLED INTO CUSTOMER CARE TO REPORT SHE IS GETTING HIGHER THAN EXPECTED BLOOD GLUCOSE READINGS. ACCORDING TO THE COMPLAINANT SHE TOOK HER DAILY SCHEDULED DOSE OF 13 UNITS OF INSULIN; AND ADMINISTERED AN ADDITIONAL 7 UNITS OF INSULIN BASED ON THE 221 MG/DL RESULT. THERE WAS NO REPORT OF ANY ADVERSE INCIDENT AS A RESULT OF ADMINISTERING OF THE EXTRA 7 UNITS OF INSULIN. THE COMPLAINANT REPORTED, "....'FELT' NORMAL BUT WAS CONCERNED ABOUT HER READINGS...."
Patient problems: Hyperglycemia
MAUDE report 6586964 ↗MalfunctionMay 24, 2017Insufficient Device Problem Information
COMPLAINANT CALLED INTO CUSTOMER CARE REPORTED HE EXPERIENCED AN HYPOGLYCEMIC EVENT THAT REQUIRED MEDICAL INTERVENTION.ACCORDING TO THE COMPLAINANT, SOMETIME BETWEEN 10:00AM AND 10:30AM, HE ATE BREAKFAST OF PANCAKES AND SYRUP AND TOOK HIS 'NORMAL' SHOT OF 20 UNITS OF INSULIN. COMPLAINTED REPORTED 'AROUND' 12:30PM HE WAS 'FEELING FINE' GOT UP TO MAKE A SANDWICH AND THE LAST THING HE REMEMBERS IS "....PASSING OUT..."
Patient problems: Hypoglycemia; Loss of consciousness
MAUDE report 6586963 ↗MalfunctionMay 24, 2017Adverse Event Without Identified Device or Use Problem
THE COMPLAINANT REPORTED TO NOVA BIOMEDICAL THAT HE WAS CONCERN ABOUT A HIGH BLOOD GLUCOSE READING HE RECEIVED ON (B)(6) 2017 AT 8:28AM. ACCORDING TO THE COMPLAINANT "....HE DID NOT FEEL AS 'HIGH' AT ALL AND HE 'FELT FINE'..." THE COMPLAINANT.
Patient problems: Hyperglycemia
MAUDE report 6586951 ↗MalfunctionMay 12, 2017Incorrect, Inadequate or Imprecise Result or Readings
A NURSE CALLED INTO CUSTOMER CARE ON BEHALF OF THE COMPLAINANT REPORTING A DISCREPANCY IN HER BLOOD GLUCOSE READINGS ON (B)(6) 2017.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6563529 ↗MalfunctionApr 28, 2017Adverse Event Without Identified Device or Use Problem
COMPLAINANT CALLED INTO CUSTOMER CARE TO REPORT HE EXPERIENCED A "HYPOGLYCEMIC INCIDENT ON (B)(6) 2017" WHICH DID NOT REQUIRE MEDICAL INTERVENTION. ON (B)(6) 2017 @7:30 PM THE COMPLAINANT PERFORMED A BLOOD GLUCOSE TEST GETTING A RESULT OF 5.9 MMOL/LAND ACCORDING OT THE COMPLAINANT HE ' FELT OK' . THE COMPLAINANT REPORTED HE ADMINISTERED 12 UNITS OF LANTUS BASED ON THE 5.9 MMOL/L RESULT.; HE ALSO REPORTED THAT HE "...NORMALLY TAKES 6-8 UNITS AT THIS TIME..." THE COMPLAINANT STATED, HE WENT TO BED A FEW HOURS LATER AND AROUND 3:00AM HE WOKE UP FEELING 'LIGHT HEADED' AND 'SWEATY'.
Patient problems: Hypoglycemia
MAUDE report 6529329 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.