OT VERIO FLEX METER 023-271

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for OT VERIO FLEX METER 023-271 manufactured by Lifescan Europe Gmbh.

MAUDE Entry Details

Report Number2939301-2020-02608
MDR Report Key9896755
Date Received2020-03-30
Date of Report2020-03-26
Date Facility Aware2020-03-26
Date Added to Maude2020-03-30
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameOT VERIO FLEX METER
Generic NameGLUCOSE MONITORING SYS/KIT
Product CodeNBW
Date Received2020-03-30
Model Number023-271
Catalog Number023-271
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerLIFESCAN EUROPE GMBH
Manufacturer AddressGUBELSTRASSE 34 ZUG 6300 CH 6300

Device Sequence Number: 101

Product Code---
Date Received2020-03-30
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention 2020-03-30

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