ACCU-CHEK ® INSTANT
Received Jul 11, 2024
Report 3011393376-2024-01435 · MDR key 19725641
Device
Product problems
- Display or Visual Feedback Problem
- Display or Visual Feedback Problem
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT RECEIVED THE METER IN THE MEASUREMENT UNITS MMOL/L FROM THEIR HEALTH INSURANCE BUT WAS EXPECTING THE METER TO GIVE RESULTS IN MG/DL. THE PATIENT INTERPRETED A VALUE OF 7.0 MMOL/L AS 70 MG/DL WHICH MADE HIM EAT MORE. THE PATIENT´S HCP NOTICED THAT THE METER PROVIDES RESULTS IN MMOL/L AND ADVISED THE PATIENT TO HAVE IT REPLACED BY A METER IN MG/DL. THE METER PROVIDED RESULTS IN MMOL/L WHICH IT WAS LABELED FOR.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ERRORS THAT OCCURRED IN THE SUBMISSION OF MDRS FOR INCORRECT MANUFACTURER NAME AND/OR ADDRESS. A NON-CONFORMANCE REPORT (NCR) ¿ 16847 TO IMPLEMENT CORRECTIVE ACTIONS WAS OPENED ON JANUARY 29, 2025. DEVICE PERFORMANCE AND/OR RISK PROFILE ARE NOT IMPACTED.