MalfunctionMMP
SITUATE
Received Apr 17, 2019 · Event occurred Aug 8, 2018
Report 3005883396-2019-00024 · MDR key 8524631
Device
Product problems
- False Negative Result
- False Negative Result
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
ONE DEVICE WAS RECEIVED FOR EVALUATION. THE RETURNED SAMPLE MET SPECIFICATION AS RECEIVED. THE VISUAL INSPECTION FOUND NO NOTABLE CONDITIONS. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CONSOLE WAS PROVIDING FALSE READINGS.