VIDAS CHLAMYDIA TRACHOMATIS TEST KIT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-10-16 for VIDAS CHLAMYDIA TRACHOMATIS TEST KIT * manufactured by Bio Meriux Of France.

Event Text Entries

[19540625] The mfr of this product, biomeriux, is telling people to use the product off label. The mfr in france has not been able to provide the test kit for many months. Since the physicians keep sending their proprietary collection device, the mfr has told customers that in lieu of using the unavailable kit to porcess the collection device, to test the device with another mfr product (syva microtrac, dfa). Neither biomeriux or syva have claim for screening pts for chlamydia using this off label method. An abstract is being sent to customers to convince them that this is acceptable. It may be acceptable to use the second kit as a confirmation method but there is no data on the use of this method to screen primary samples. The abstract illustrates that the suggested off label method is actually less sensitive and could therefore cause false negative reports for this dangerous disease.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1023102
• MDR Report Key: 356369
• Date Received: 2001-10-16
• Date of Report: 2001-10-09
• Date Added to Maude: 2001-10-22
• 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
• 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 Details

• Brand Name: VIDAS CHLAMYDIA TRACHOMATIS TEST KIT
• Generic Name: DIAGNOSTIC TEST FOR INFECTIOUS DISEASE
• Product Code: LJC
• Date Received: 2001-10-16
• Model Number: *
• Catalog Number: *
• Lot Number: ALL
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 345593
• Manufacturer: BIO MERIUX OF FRANCE
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-10-16