ANTI-DS DNA EIA * 31008

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-16 for ANTI-DS DNA EIA * 31008 manufactured by Bio-rad Laboratories Diagnostics Group.

Event Text Entries

[286460] Problems started 7/02 and continued through 10/02 lot 025773 exp. 5-21-03, lot 026556 exp. 7-9-03, lot 026645 exp. 9-10-03. All lots were bad and eventually recalled by vendor.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1027007
• MDR Report Key: 433811
• Date Received: 2002-12-16
• Date of Report: 2002-12-16
• Date Added to Maude: 2002-12-24
• 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: OTHER HEALTH CARE PROFESSIONAL
• 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: ANTI-DS DNA EIA
• Generic Name: IN VITRO DIAGNOSTIC TEST FOR ANTI-DS DNA
• Product Code: KTL
• Date Received: 2002-12-16
• Model Number: *
• Catalog Number: 31008
• Lot Number: 025773
• ID Number: BIORAD KALLESTAD ANTI-DSDNA
• Device Expiration Date: 2003-05-21
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 422752
• Manufacturer: BIO-RAD LABORATORIES DIAGNOSTICS GROUP
• Manufacturer Address: 4000 ALFRED NOBEL DRIVE HERCULES CA 94547 US

Device Sequence Number: 2

• Brand Name: ANTI-DS DNA EIA
• Generic Name: IN VITRO DIAGNOSTIC TEST FOR ANTI-DS DNA
• Product Code: KTL
• Date Received: 2002-12-16
• Model Number: *
• Catalog Number: 31008
• Lot Number: 026557
• ID Number: BIORAD KALLESTAD ANTI-DSDNA
• Device Expiration Date: 2003-07-09
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 422753
• Manufacturer: BIO-RAD LABORATORIES, DIAGNOSTICS GROUP
• Manufacturer Address: 4000 ALFRED NOBEL DRIVE HERCULES CA 94547 US

Device Sequence Number: 3

• Brand Name: ANTI-DS DNA EIA
• Generic Name: IN VITRO DIAGNOSTIC TEST FOR ANTI-DS DNA
• Product Code: KTL
• Date Received: 2002-12-16
• Model Number: *
• Catalog Number: 31008
• Lot Number: 026645
• ID Number: BIORAD KALLESTAD ANTI-DSDNA
• Device Expiration Date: 2003-09-10
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 422754
• Manufacturer: BIO-RAD LABORATORIES, DIAGNOSTICS GROUP
• Manufacturer Address: 4000 ALFRED NOBEL DRIVE HERCULES CA 94547 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-12-16