SEDLINE MODULE
Received May 31, 2026 · Event occurred Jan 1, 2026
Report 3019388613-2026-00271 · MDR key 25344420
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
OTHER, OTHER TEXT: THE DEVICE HAS NOT BEEN RETURNED TO THE INVESTIGATION FACILITY TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. WHEN THE DEVICE IS RECEIVED FOR EVALUATION OR IF NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. E1. INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, ZIP CODE IS AS FOLLOWS:(B)(6). E1. INITIAL REPORTER PHONE NUMBER EXCEEDED MAXIMUM ALLOWABLE DIGITS, PHONE NUMBER IS AS FOLLOWS: (B)(6). HEALTH EFFECT IMPACT CODE: NO ADVERSE EVENT; NO PATIENT IMPACT H3 OTHER TEXT : PRODUCT NOT RETURNED TO INVESTIGATION FACILITY.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE MODULE IS NOT GIVING CORRECT READINGS. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Remedial action
- Other