MalfunctionPSZ

BINAX NOW INFLUENZA A&B CARD 2

Received Apr 10, 2020 · Event occurred Jan 19, 2020

Report 9947849 · MDR key 9947849

Device

Generic name

Influenza Rapid Test

Manufacturer

Alere Scarborough, Inc.

Catalog number

575-000

Lot number

1112145

Product problems

Material Integrity Problem

Patient

1460 DA

Discomfort
Discomfort

Narrative

Description of Event or Problem

NP (NURSE PRACTITIONER) SWABBED PEDIATRIC PATIENT FOR FLU AND PUT SWAB INTO ELUTION VIAL AND VERY LITTLE SOLUTION IN ELUTION VIAL. SWAB DISCARDED. NP DECIDED TO NOT RE-SWAB TO RUN TEST SINCE PATIENT WAS NOT COOPERATIVE WITH FIRST SWAB. MANUFACTURER RESPONSE FOR INFLUENZA RAPID TEST, BINAX NOW INFLUENZA A&B CARD 2 (PER SITE REPORTER). REPORTED EQUIPMENT FAILURE TO ABBOTT TECHNICAL SERVICES ((B)(4)).