PROFILE-V 4881 604022

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-23 for PROFILE-V 4881 604022 manufactured by Medtox Diagnostics, Inc..

Event Text Entries

[21659653] Emergency room phyicians noted an abnormal increase in positive toxicology screens. Questioning the lab, it was found that there had been an "urgent medical device recall" on medtox devices used for qualitative detection of "drugs of abuse" in human urine. An all inclusive list of patients with resulting positive urine tox screens using the recall involved lot numbers was produced. Follow-up with patients and family is in progress. Manufacturer provided replacement to all affected lots. What was the original intended procedure? Urine tox screening. Device #1is this a laboratory device or laboratory test? Yes. This problem involved: other. If you answered other to the question above, please specify:profile-v medtox scan test devices - 13 panel. Is this a recurring problem with this assay, test kit or instrument? Yes. If you answered yes to the question above, please provide additional comments:physicians noted what appeared to be abnormally high positive tox screenswhich of the following problems did you observe:questionable patient results. Please describe any follow up actions:discontinued all use of product. Manufacturer notified.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3091408
• MDR Report Key: 3091408
• Date Received: 2013-04-23
• Date of Report: 2013-04-23
• Date of Event: 2013-04-22
• Report Date: 2013-04-23
• Date Reported to FDA: 2013-04-23
• Date Reported to Mfgr: 2013-05-03
• Date Added to Maude: 2013-05-03
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PROFILE-V
• Generic Name: URINE ANALYZER
• Product Code: DJG
• Date Received: 2013-04-23
• Returned To Mfg: 2013-02-01
• Model Number: 4881
• Catalog Number: 604022
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: R
• Device Age: 2.5 MO
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTOX DIAGNOSTICS, INC.
• Manufacturer Address: 1238 ANTHONY RD. BURLINGTON NC 27215 US 27215

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-04-23