CONTOUR® NEXT LINK 6207Recalls & reported problems
Ascensia Diabetes Care US Inc. · Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the following items: CONTOUR® NEXT LINK Blood Glucose Meter; 25 CONTOUR® NEXT Blood Glucose Test Strips; CONTOUR® NEXT Level 2 Control Solution; MICROLET® 2 Lancing Device; Alternative Site Endcap; Adjustable Endcap; 25 Lancets (provided sterile); Quick Reference Guide; Wall Charger; User Guide; USB Extension Cable; Logbook; Carrying Case. · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00301936207014), received between May 23, 2019 and May 23, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Missing Test Results” (1 report).
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
- Missing Test Results1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2019Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT THE BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF HIS CONTOUR NEXT LINK 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 8637100 ↗
Other Single (Specified) Analyte Controls (Assayed And Unassayed) devices
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- CONTOUR® NEXT 7377Ascensia Diabetes Care US Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)95 reports
- ARCHITECT 7K62-25Abbott Ireland · SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)94 reports
- ARCHITECT 08K2812Abbott GmbH · Single (specified) analyte controls (assayed and unassayed)1 recall12 reports
- CONTOUR® NEXT 9697Ascensia Diabetes Care US Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)56 reports
- VITROS 6192257Ortho Clinical Diagnostics · Single (specified) analyte controls (assayed and unassayed)1 recall0 reports
- McKesson 5011Mckesson Medical-Surgical Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.