CONTOUR® 9545CRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00301939545014), received between Nov 6, 2018 and Jan 4, 2023 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (14 reports).

2 other recalls cover devices cleared under the same FDA submission (K062058); 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.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2023Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAD ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16094368 ↗
• MalfunctionMay 24, 2022Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAD ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489628 ↗
• MalfunctionOct 1, 2021Missing Test Results; Missing Test Results

  AN ADVOCATE CALLED TO REPORT THAT THE CUSTOMER'S BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12561794 ↗
• MalfunctionJul 1, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING PROPERLY STORED IN THE MEMORY OF THE CONTOUR METER. FOR EXAMPLE, THE CUSTOMER OBTAINED A READING OF 100 MG/DL, WHICH WAS INCORRECTLY STORED. IN ANOTHER INSTANCE, A READING OF 100 MG/DL WAS STORED AS 86 MG/DL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12098743 ↗
• MalfunctionJun 1, 2021Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HER BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913702 ↗
• InjuryMay 5, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT HE ATE BREAKFAST AND RAN A BLOOD GLUCOSE TESTING ON HIS CONTOUR METER OBTAINING A READING OF 95 MG/DL AT 9:00 A.M. THE CUSTOMER TOOK HIS USUAL DOSAGE OF 500 MG OF METFORMIN. THE CUSTOMER WENT TO HIS BROTHER'S HOUSE AND PERFORMED ANOTHER TESTING WITH HIS MOTHER'S BLOOD GLUCOSE MONITORING SYSTEM OBTAINING A READING OF OVER 700 MG/DL, WHICH MATCHED WITH HIS SYMPTOMS OF HYPERGLYCEMIA SUCH AS DIZZINESS, TROUBLE THINKING AND SPEAKING. THE CUSTOMER WAS DRIVEN TO THE HOSPITAL IMMEDIATELY AND HE PASSED OUT IN THE CAR. IN THE HOSPITAL, THE CUSTOMER WAS PUT UNDER INDUCED COMA AND TREATED FOR HYPERGLYCEMIA. THE CUSTOMER WAS TREATED WITH THE INTRAVENOUS INSULIN IN THE HOSPITAL. THE CUSTOMER RECOVERED WELL AFTER THE TREATMENT AND WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: Dizziness; Hyperglycemia; Loss of consciousness

  MAUDE report 11777277 ↗
• MalfunctionNov 5, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR METER. THE CUSTOMER HAD CHANGED THE METER'S BATTERY A DAY BEFORE THE EVENT. THE DATE AND TIME ON THE METER WERE SET INCORRECTLY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10790991 ↗
• MalfunctionOct 5, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10627312 ↗
• MalfunctionSep 22, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HIS BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. THE CUSTOMER WAS OFFERED A REPLACEMENT DEVICE, HOWEVER, THE CUSTOMER DECLINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10566642 ↗
• MalfunctionSep 8, 2020Missing Test Results; Missing Test Results

  AN ADVOCATE FROM (B)(6) REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10503425 ↗
• MalfunctionSep 1, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HIS BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10477984 ↗
• MalfunctionAug 4, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT ONE OF HER BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10361532 ↗
• MalfunctionJul 30, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE RAN BLOOD GLUCOSE TESTS ON HIS CONTOUR METER AND OBTAINED READINGS OF LO (INDICATIVE OF A READING BELOW 10 MG/DL), 40 MG/DL, 247 MG/DL, AND 167 MG/DL. THE CUSTOMER ALSO RAN BLOOD GLUCOSE ON AN ALTERNATE CONTOUR METER AND OBTAINED READINGS OF 110 MG/DL, 115 MG/DL, 112 MG/DL, AND 108 MG/DL. ALL READINGS WERE OBTAINED WITHIN 10 MINUTES. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER DECLINED TO RETURN THE DEVICE. THEREFORE, THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10343269 ↗
• MalfunctionJul 30, 2020Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 265 MG/DL, 43 MG/DL AND 280 MG/DL WITHIN 10 MINUTES ON THE CONTOUR METER. THE CUSTOMER HAD NO SYMPTOMS OF HYPOGLYCEMIA. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER DECLINED TO RETURN THE DEVICE. THEREFORE, THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10343268 ↗
• MalfunctionJan 22, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READING WAS NOT BEING STORED IN THE MEMORY OF THE CONTOUR METER. DURING THE FOLLOW-UP, CUSTOMER PERFORMED ANOTHER TESTING AND THE READING OBTAINED WAS PROPERLY STORED IN METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9615393 ↗
• MalfunctionJan 3, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READING WAS NOT BEING STORED IN THE MEMORY OF THE CONTOUR METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9543996 ↗
• InjuryOct 4, 2019High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED A BLOOD GLUCOSE READING OF 250 MG/DL ON THE CONTOUR METER. THE CUSTOMER BECAME UNCONSCIOUS. THE PARAMEDIC WAS CALLED AND THE CUSTOMER WAS TAKEN TO AN EMERGENCY ROOM. THE CUSTOMER STATED THAT A TEST WAS PERFORMED IN THE HOSPITAL WITH THEIR METER AND A READING OF 23 MG/DL WAS OBTAINED. THE CUSTOMER STATED THAT BOTH READINGS WERE TAKEN 10 MINUTES APART. THE CUSTOMER DID NOT REMEMBER IF SHE RECEIVED ANY TREATMENT. NO FURTHER EVENT DETAILS WERE PROVIDED. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: Loss of consciousness

  MAUDE report 9158038 ↗
• MalfunctionOct 2, 2019High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE PERFORMED A BLOOD GLUCOSE TESTING ON HIS CONTOUR METER AND OBTAINED A HI READING, WHICH WAS INDICATIVE OF A READING ABOVE 600 MG/DL. THE CUSTOMER HAD NO SYMPTOMS OF HYPERGLYCEMIA. WITHIN 2 MINUTES, THE CUSTOMER PERFORMED A REPEAT TESTING WITH THE NON-ASCENSIA METER AND OBTAINED A READING OF 128 MG/DL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION, HOWEVER, THE CUSTOMER DISCARDED THE TEST STRIPS. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9144604 ↗
• InjuryApr 5, 2019High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED A HIGH BLOOD GLUCOSE READING ON HIS CONTOUR METER. NO SPECIFIC READING WAS PROVIDED. BASED ON THE HIGH READING, THE CUSTOMER TOOK 10 EXTRA UNITS OF INSULIN ON TOP OF HIS REGULAR PRESCRIPTION. AFTER THAT, HE FELT LOW BLOOD SUGAR SYMPTOMS SUCH AS LACK OF FOCUS, INDIGESTION AND DIZZINESS. HE WENT TO THE HOSPITAL FOR A REGULAR APPOINTMENT. AFTER ARRIVING AT THE HOSPITAL, THE NURSE CHECKED HIS BLOOD GLUCOSE AND A READING OF 47 MG/DL WAS OBTAINED. ABOUT AN HOUR LATER, ANOTHER TEST WAS RUN WITH THE HOSPITAL'S METER AND A READING OF 87 MG/DL WAS OBTAINED. THE CUSTOMER WAS GIVEN SUGAR WATER AT THE HOSPITAL. AFTER THIS, THE NURSE RAN ANOTHER BLOOD GLUCOSE TEST AND OBTAINED READINGS OF 127 MG/DL WITH THE HOSPITAL'S METER AND 360 MG/DL WITH THE CUSTOMER'S CONTOUR METER, BOTH TAKEN WITHIN TWO MINUTES. THE CUSTOMER WAS HOSPITALIZED FOR THREE DAYS. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: Dizziness; Hypoglycemia

  MAUDE report 8486343 ↗
• MalfunctionFeb 25, 2019Missing Test Results; Missing Test Results

  THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE READINGS BETWEEN (B)(6) 2018 WERE NOT STORED IN THE MEMORY OF A CONTOUR METER. THERE WAS NO ALLEGATION OF ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8367662 ↗
• MalfunctionNov 6, 2018Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED FOR HELP WITH HIS CONTOUR METER. DURING TROUBLESHOOTING, THE CUSTOMER WAS NOT ABLE TO FIND HIS MOST RECENT BLOOD GLUCOSE READING IN THE MEMORY OF THE METER. NO ADVERSE EVENT ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8042932 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062058. One submission often covers many models, so check the product and lot details in each record.

• Z-3268-2011 · Aug 12, 2011 · Terminated
  Contour, Contour TS Blood Glucose Test Strips and Bonus Packs Intended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in w
• Z-1001-2007 · Jun 6, 2007 · Terminated
  Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---.