FDA Adverse Event Malfunction Summary report: N

QT MICRO SYSTEM

MDR report key: 6348655 · Received February 20, 2017

Report

Report Number
MW5067980
Event Type
Malfunction
Date Received
February 20, 2017
Date of Event
February 20, 2017
Report Date
February 20, 2017
Manufacturer
Q.I. MEDICAL, INC.
Product Code
LHI
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PHARMACIST

Narratives

Description of Event or Problem · 1

PHARMACY TECHNICIAN OPENED QT MICRO SYSTEM CATALOG #TM6000, LOT# B16-2279, EXP. 02/2021 AND THE WHITE CAP WAS MISSING FROM THE PACKAGING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
126525 QT MICRO SYSTEM QT MICRO SYSTEM LHI Q.I. MEDICAL, INC. B16-2279

Patients

Seq Age Sex Outcome Treatment
1