CONTOUR NEXT GENRecalls & reported problems across all models
Ascensia Diabetes Care US Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one CONTOUR NEXT GEN model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 85
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 5 models of CONTOUR NEXT GEN by Ascensia Diabetes Care US Inc. in the FDA's device registry (GUDID). Together they are named in 85 adverse event reports in the FDA's MAUDE database, received between May 22, 2023 and Jan 7, 2026 — classified as 1 injury, 84 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (50 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
CONTOUR NEXT GEN recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 19, 2023Open, Classified
Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters distributed in the United States were packaged into the meter kit and had incorrect factory-set unit of measure where the meters display glucose results in mmol/L rather than mg/dL. The standard unit of measurement for the United States is mg/dL. If a consumer does not notice the incorrect unit of measurement, it is possible that the meters glucose measurement will be read as a lower blood glucose measurement than expected, and this may result in the patients glucose level remaining high, which can potentially lead to an injury requiring immediate medical intervention.
Z-2211-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported CONTOUR NEXT GEN problems
Device problems
- Nonstandard Device50
- Missing Test Results27
- Incorrect, Inadequate or Imprecise Result or Readings4
- Data Problem1
- High Readings1
- Low Readings1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions84
- Insufficient Information1
CONTOUR NEXT GEN models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CONTOUR® NEXT GEN 7917System, Test, Blood Glucose, Over The Counter1 recall55 reports
- CONTOUR® NEXT GEN 9732System, Test, Blood Glucose, Over The Counter14 reports
- CONTOUR® NEXT GEN 9658System, Test, Blood Glucose, Over The Counter8 reports
- CONTOUR® NEXT GEN 7383System, Test, Blood Glucose, Over The Counter7 reports
- CONTOUR® NEXT GEN 7922System, Test, Blood Glucose, Over The Counter1 report
Recent CONTOUR NEXT GEN adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2026Data Problem
THE CUSTOMER REPORTED RECEIVING A NEW CONTOUR® NEXT GEN METER FROM A HEALTHCARE PROFESSIONAL, WHICH ALREADY CONTAINED 25 BLOOD GLUCOSE READINGS IN THE METER'S MEMORY. 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 23995434 ↗MalfunctionSep 10, 2025Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR® NEXT GEN METER. THE CUSTOMER STATED THAT SHE HAD CHANGED THE DATE AND TIME SETTINGS ON THE 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 23016614 ↗MalfunctionSep 2, 2025Nonstandard Device; Nonstandard Device
A CUSTOMER CALLED TO REPORT THAT SHE PURCHASED A CONTOUR® NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. THE CUSTOMER PROVIDED EXAMPLES OF BLOOD GLUCOSE READINGS FROM THE METER'S MEMORY AS 20.6 MMOL/L, 19.4 MMOL/L, 18.9 MMOL/L, 17.5 MMOL/L AND 10.7 MMOL/L. 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 22939428 ↗MalfunctionAug 21, 2025Nonstandard Device; Nonstandard Device
A CUSTOMER CALLED TO REPORT THAT SHE PURCHASED A CONTOUR® NEXT GEN METER IN THE US AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. THE CUSTOMER PROVIDED AN EXAMPLE OF A BLOOD GLUCOSE READING FROM THE METER'S MEMORY AS 5.2 MMOL/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER REFUSED TO RETURN THE DEVICE. ALTHOUGH THE CUSTOMER WAS OFFERED A REPLACEMENT METER KIT, THE CUSTOMER REFUSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22861741 ↗MalfunctionJul 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A DISCREPANCY IN THE SERVICE MODE OF THE CONTOUR® NEXT GEN METER, WHICH DISPLAYED 97 READINGS, DESPITE THE CUSTOMER HAVING CONDUCTED ONLY 73 BLOOD GLUCOSE TESTS TILL (B)(6) 2025. 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 22583506 ↗MalfunctionJul 8, 2025Nonstandard Device; Nonstandard Device
A CUSTOMER CALLED TO REPORT THAT SHE PURCHASED A CONTOUR® NEXT GEN METER IN THE US AND THE METER 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. 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 22436762 ↗MalfunctionJun 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 495 MG/DL AND 78 MG/DL WITH THE CONTOUR® NEXT GEN METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE CUSTOMER DECLINED TO RECEIVE THE REPLACEMENT METER. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22205702 ↗MalfunctionMar 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT THE CONTOUR® NEXT GEN METER DISPLAYED BLOOD GLUCOSE READINGS OF 515 MG/DL AT 10:33 A.M. AND 424 MG/DL AT 5:33 P.M. THE CUSTOMER STATED THAT HE DID NOT PERFORM THESE READINGS AND DID NOT SHARE THE METER WITH ANYONE ELSE. 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 21596235 ↗MalfunctionMar 13, 2025Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR® NEXT GEN 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 21596232 ↗MalfunctionMar 3, 2025Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR® NEXT GEN 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 21504297 ↗MalfunctionMar 3, 2025Missing Test Results; Missing Test Results
THE CUSTOMER CONTACTED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH HIS CONTOUR® NEXT GEN METER. DURING THE TROUBLESHOOTING, IT WAS FOUND THAT ONE OF THE CUSTOMER'S BLOOD GLUCOSE READINGS WAS NOT STORED IN THE METER'S MEMORY. 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 21504292 ↗MalfunctionFeb 11, 2025Missing Test Results; Missing Test Results
THE CUSTOMER CONTACTED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH HER CONTOUR® NEXT GEN METER. DURING THE TROUBLESHOOTING, IT WAS FOUND THAT THE CUSTOMER'S BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE METER'S MEMORY. 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 21354543 ↗MalfunctionJan 2, 2025Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR® NEXT GEN METER. THE CUSTOMER HAD CHANGED THE METER BATTERIES ON (B)(6)2024. 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 21057263 ↗MalfunctionJan 2, 2025Nonstandard Device; Nonstandard Device
A CUSTOMER CALLED TO REPORT THAT HE PURCHASED A CONTOUR® NEXT GEN METER IN THE US FROM AMAZON WEBSITE AND THE METER 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. 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 21057259 ↗MalfunctionJan 2, 2025Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR® NEXT GEN METER. THE CUSTOMER HAD CHANGED THE METER BATTERIES ON (B)(6) 2024. 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 21057257 ↗
Other Ascensia Diabetes Care US Inc. products
All Ascensia Diabetes Care US Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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