NOVA MAX LinkRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00385480445856), received between Mar 3, 2017 and Jun 15, 2020 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2020No Display/Image; Missing Test Results; No Display/Image; Missing Test Results

  THE COMPLAINANT STATED THE LAST DIGIT IS MISSING FROM THE RESULTS SEGMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10153120 ↗
• MalfunctionFeb 11, 2020High Readings

  COMPLAINANT CALLED TO REPORT "HIGH BG (BLOOD GLUCOSE) READINGS". THE COMPLAINANT STATED SHE CORRECTED HER INSULIN INTAKE FOR SOME BLOOD GLUCOSE READINGS. THE COMPLAINANT DOES NOT REMEMBER FOR WHICH BLOOD GLUCOSE READING SHE CORRECTED HER INSULIN INTAKE. SHE FURTHER STATES SHE CORRECTED HER INSULIN "MULTIPLE TIMES THROUGHOUT THE DAY". AFTER TESTING HERSELF MANY TIMES SHE DECIDED TO GO TO THE ER DUE TO HER HIGH BLOOD GLUCOSE READINGS AND SYMPTOMS. COMPLAINANT STATED SHE NOTICED SHE WAS HAVING "SYMPTOMS RELATED TO LOW BLOOD GLUCOSE SUGAR" WHILE SHE WAS READING HIGH. SHE STATED SHE "FELT DIZZY, CONFUSED, HAD A HEADACHE AND FELT TIRED". COMPLAINANT ARRIVED AT THE HOSPITAL "APPROXIMATELY" 1PM, THE NURSE DISCONNECTED HER INSULIN PUMP. THE COMPLAINANT WAS MAINLY UNDER OBSERVATION AT THE HOSPITAL. NO MEDICATION WAS GIVEN, ONLY FOOD AND JUICE. WHILE AT THE HOSPITAL HER HUSBAND BROUGHT A NEW VIAL OF NOVA MAX GLUCOSE TEST STRIPS. COMPLAINANT DID NOT HAVE THE LOT NUMBER OF THE NEW VIAL. THE COMPLAINANT TESTED HER BG USING HOSPITALS UNK METER AGAINST HER NOVA MAX LINK (NML) METER USING THE NEW VIAL OF NOVA MAX GLUCOSE TEST STRIPS. HOSPITAL'S UNK METER RESULT WAS 84 AND NML METER READ 86. THE COM

  Patient problems: Hypoglycemia; Patient Problem/Medical Problem

  MAUDE report 9693915 ↗
• MalfunctionOct 19, 2018High Readings

  CUSTOMER CONCERNED ABOUT HER HIGH BLOOD GLUCOSE READINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7986844 ↗
• MalfunctionDec 29, 2017Adverse Event Without Identified Device or Use Problem

  COMPLAINANT CALLED IN CONCERNED ABOUT HER READINGS AND REPORTED THAT "...BECAUSE OF HER BLOOD SUGAR, SHE WAS INVOLVED IN A CAR ACCIDENT..."

  Patient problems: No Code Available

  MAUDE report 7154953 ↗
• MalfunctionDec 15, 2017Incorrect Or Inadequate Test Results

  COMPLAINANT'S DAUGHTER, (B)(6), CALLED IN TO REPORT A DISCREPANCY BETWEEN HER MOTHER'S NOVA MAX LINK METER AND HER FATHER'S UNKNOWN BRAND METER.

  Patient problems: No Information

  MAUDE report 7121552 ↗
• MalfunctionNov 9, 2017Insufficient Device Problem Information

  COMPLAINANT REPORTED TO NOVA BIOMEDICAL REPORTING AN INCIDENT ON (B)(6) 2017 WHERE THE EMTS WERE CALLED TO HER HOUSE.

  Patient problems: No Information

  MAUDE report 7015029 ↗
• MalfunctionNov 2, 2017Appropriate Device Problem Term/Code Not Available

  COMPLAINANT REPORTED TO NOVA BIOMEDICAL A CONCERN ABOUT A DISCREPANCY BETWEEN HER READINGS.

  Patient problems: No Information

  MAUDE report 6995657 ↗
• MalfunctionOct 18, 2017Insufficient Device Problem Information

  COMPLAINANT REPORTED AN INCIDENT THAT HAPPENED ON (B)(6) 2017 WHEN HE WAS TALKING ON THE PHONE WITH HIS SISTER LATER AT NIGHT WHEN SHE EXPRESSED HER CONCERNS WHEN HE STARTED TO SOUND INCOHERENT.

  Patient problems: Hypoglycemia

  MAUDE report 6957696 ↗
• MalfunctionOct 18, 2017Adverse Event Without Identified Device or Use Problem

  COMPLAINANT CALLED INTO CUSTOMER CARE TO REPORT HER CONCERNS ABOUT HIGHER THAN EXPECTED BLOOD GLUCOSE RESULTS.

  Patient problems: Hyperglycemia

  MAUDE report 6957565 ↗
• MalfunctionOct 6, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NOVA BIOMEDICAL THAT THE COMPLAINANT "...AT APPROXIMATELY 2:50AM SHE ROLLED OUT OF BED, FELL ON THE FLOOR AND HIT HER HEAD..." THE COMPLAINANT WAS BROUGHT TO THE EMERGENCY ROOM.

  Patient problems: Fall; Head Injury

  MAUDE report 6925892 ↗
• MalfunctionOct 4, 2017Insufficient Device Problem Information

  ACCORDING TO THE COMPLAINANT'S HUSBAND, THE COMPLAINANT 'CRASHED HER CAR' ON (B)(6) 2017 DUE TO A "...HYPOGLYCEMIC EVENT POSSIBLY STEMMING FROM INSULIN TAKEN BASED ON AN INACCURATE BLOOD GLUCOSE READING FROM HER NOVA MAX LINK METER ON THE DAY IN QUESTION..."

  Patient problems: Hypoglycemia

  MAUDE report 6913579 ↗
• MalfunctionMar 29, 2017Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE COMPLAINANT WHOM CALLED INTO CUSTOMER CARE FROM HIS HOSPITAL BED TO REPORT HE HAD TO BE TRANSPORTED TO THE EMERGENCY ROOM BECAUSE HE 'COLLAPSED' ON (B)(6) 2017. HE WAS FOUND BY HIS WIFE, MRS (B)(6) WHO DESCRIBED HIM AS 'GASPING' FOR AIR WHEN HE WOKE UP. SHE CALLED EMTS AND WHEN THEY ARRIVED THEY PERFORMED A BLOOD GLUCOSE TEST USING THEIR UNKNOWN METER GETTING A RESULT IN THE '600'S'.

  Patient problems: Collapse; Hyperglycemia

  MAUDE report 6442085 ↗
• MalfunctionMar 3, 2017Insufficient Device Problem Information

  COMPLAINANT CALLED BACK INTO THE CUSTOMER CARE DEPARTMENT TO REPORT SHE EXPERIENCED ANOTHER EVENT CAUSING HER TO BE TRANSPORTED TO THE EMERGENCY ROOM. THE COMPLAINANT REPORTED SHE CONTINUED TO USE THE METER AND STRIPS FROM THE SAME VIAL THAT SHE USED IN HER FIRST EVENT.

  Patient problems: No Information

  MAUDE report 6376165 ↗
• MalfunctionMar 3, 2017Insufficient Device Problem Information

  COMPLAINANT CALLED IN REPORTING HIGH BLOOD GLUCOSE READINGS.

  Patient problems: Hyperglycemia

  MAUDE report 6376126 ↗