CONTOUR® 9556CRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00301939556010), received between Aug 17, 2018 and Nov 21, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Nonstandard Device; Nonstandard Device

  A CUSTOMER REPORTED THAT SHE PURCHASED THE CONTOUR® METER FROM THEIR LOCAL PHARMACY IN THE US, WHICH WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619657 ↗
• MalfunctionMar 24, 2025Missing Test Results; Missing Test Results

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE ASCENSIA METER. DURING TROUBLESHOOTING, IT WAS FOUND 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 21677303 ↗
• MalfunctionMay 25, 2021Missing 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. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11877582 ↗
• MalfunctionJun 4, 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. 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 10119018 ↗
• MalfunctionMar 26, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THERE WAS A DIFFERENCE OF 20 TO 30 MG/DL BETWEEN THE BLOOD GLUCOSE READINGS OBTAINED ON THE CONTOUR METER AND ANOTHER METER. NO SPECIFIC READINGS WERE PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE 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: No Known Impact Or Consequence To Patient

  MAUDE report 9884199 ↗
• MalfunctionFeb 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT AT 7:55 A.M., SHE OBTAINED A BLOOD GLUCOSE READING OF 291 MG/DL ON HER CONTOUR METER. SHE PERFORMED ANOTHER TEST AT 8:00 A.M. WITH HER CONTOUR NEXT ONE METER AND OBTAINED A READING OF 127 MG/DL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE PRODUCT 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: No Known Impact Or Consequence To Patient

  MAUDE report 9658936 ↗
• MalfunctionJan 7, 2020Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READINGS AND 14 DAYS AVERAGE WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR METER. DURING THE CALL, IT WAS FOUND THAT 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 METER WAS EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9558540 ↗
• MalfunctionSep 25, 2019Missing Test Results; Missing Test Results

  THE CUSTOMER REPORTED THAT HIS 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 METER FOR EVALUATION. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9118447 ↗
• MalfunctionAug 1, 2019High Readings; High Readings

  THE PARAMEDICS CALLED TO REPORT THAT THEY PERFORMED A BLOOD GLUCOSE TEST ON A PATIENT WITH THEIR CONTOUR METER AND OBTAINED A READING OF 98 MG/DL. UPON REPEAT TESTING WITH THE HOSPITAL'S METER, A READING OF 36 MG/DL WAS OBTAINED. NO FURTHER EVENT DETAILS WERE PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. NO FOLLOW-UP COULD BE ESTABLISHED WITH THE PARAMEDICS, THEREFORE, NO REPLACEMENT PRODUCT WAS SENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED. 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 8850236 ↗
• MalfunctionAug 17, 2018Missing Test Results; Missing Test Results

  THE CUSTOMER INITIALLY CALLED FOR ASSISTANCE WITH SUSPECTED HIGH READINGS. THE COMPLAINT DID NOT MEET THE CRITERIA TO BE REPORTED. DURING THE CALL WHEN ACCESSING THE MEMORY TO VIEW THE READINGS, THE CUSTOMER WAS NOT ABLE TO FIND THE READINGS, AND ALLEGED THE CONTOUR WAS NOT RETAINING THEM. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION. A NEW METER WAS SENT TO HER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7794682 ↗

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---.