URS - IK URINALYSIS STRIPS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-02-06 for URS - IK URINALYSIS STRIPS * manufactured by L.w. Scientific, Inc..

Event Text Entries

[307667] Urine ketone strips reading false positive that lead to hospitalization of the pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1027455
• MDR Report Key: 441926
• Date Received: 2003-02-06
• Date of Report: 2003-01-26
• Date of Event: 2002-12-01
• Date Added to Maude: 2003-02-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: URS - IK URINALYSIS STRIPS
• Generic Name: URINE REAGENT STRIPS
• Product Code: JIL
• Date Received: 2003-02-06
• Model Number: *
• Catalog Number: *
• Lot Number: B10078
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 430901
• Manufacturer: L.W. SCIENTIFIC, INC.
• Manufacturer Address: * TUCKER GA * US

Device Sequence Number: 2

• Brand Name: URS -IK URINALYSIS STRIPS
• Generic Name: URINE REAGENT STRIPS
• Product Code: JRE
• Date Received: 2003-02-06
• Model Number: *
• Catalog Number: *
• Lot Number: C10563
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 430902
• Manufacturer: L.W. SCIENTIFIC, INC.
• Manufacturer Address: * TUCKER GA * US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2003-02-06