MalfunctionOZE
ACCULA FLU A / FLU B TEST
Received Feb 13, 2023 · Event occurred Jan 16, 2023
Report 3013022608-2023-00374 · MDR key 16369032
Device
Generic name
Respiratory Viral Panel Multiplex Nucleic Acid Assay
Manufacturer
Mesa BiotechModel number
FAB1100CWLot number
P22314-022
Product problems
- False Negative Result
- False Negative Result
Patient
0 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MESA CONTINUES TO TRACK, TREND, CAPA ASSIGNED, AND REACT TO CUSTOMER COMPLAINTS. NO ADVERSE EVENT OCCURRED. THE MANUFACTURER HAS NOT CONFIRMED THAT THE DEVICE MALFUNCTIONED. INFORMATION REPORTED BY USER IS BEING REPORTED AS REQUIRED BY 21 CFR 803.
Description of Event or Problem
CUSTOMER REPORTED FALSE NEGATIVE. INFORMATION REPORTED BY USER IS BEING REPORTED AS REQUIRED BY 21 CFR 866.3980.
Remedial action
- Other