DIRECT LDL CHOLESTEROL REAGENT (REF 969706) *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-09-18 for DIRECT LDL CHOLESTEROL REAGENT (REF 969706) * manufactured by Beckman Coulter.

Event Text Entries

[513110] Beckman coutler synchron system direct ldl cholesterol reagent (ref # 969706). Test kits produced in 2006 are giving falsely elevated direct ldl results. Values are falsely increased by 15-35%. Lot # m604001, m603001, m602001, m601001. Elevated results may cause physicians to put patient on prescription they do not need or inappropriate dosage.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1040448
• MDR Report Key: 761802
• Date Received: 2006-09-18
• Date of Report: 2006-09-18
• Date of Event: 2006-09-14
• Date Added to Maude: 2006-09-20
• 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: 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 Sequence Number: 1

• Brand Name: DIRECT LDL CHOLESTEROL REAGENT (REF 969706)
• Generic Name: SYNCHRON SYSTEM LDLD
• Product Code: LBS
• Date Received: 2006-09-18
• Model Number: *
• Catalog Number: *
• Lot Number: M604001
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 749698
• Manufacturer: BECKMAN COULTER
• Manufacturer Address: 200 S. KRAEMER BLVD P.O.BOX 8000 BREA CA * US

Device Sequence Number: 2

• Brand Name: DIRECT LDL CHOLESTEROL REAGENT (REF 989706)
• Generic Name: SYNCHRON SYSTEMS LDLD
• Product Code: LBS
• Date Received: 2006-09-18
• Model Number: *
• Catalog Number: *
• Lot Number: M603001
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 750403
• Manufacturer: BECKMAN COULTER
• Manufacturer Address: 200 S. KRAEMER BLVD P.O. BOX 8000 BREA CA * US

Device Sequence Number: 3

• Brand Name: DIRECT LDL CHOLESTEROL REAGENT (REF 969706)
• Generic Name: SYNCHRON SYSTEM LDLD
• Product Code: LBS
• Date Received: 2006-09-18
• Model Number: *
• Catalog Number: *
• Lot Number: M602001
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 750408
• Manufacturer: BECKMAN COULTER
• Manufacturer Address: 200 S. KRAEMER BLVD P.O. BOX 8000 BREA CA * US

Device Sequence Number: 4

• Brand Name: DIRECT LDL CHOLESTEROL REAGENT (REF 989706)
• Generic Name: SYNCHRON SYSTEM LDLD
• Product Code: LBS
• Date Received: 2006-09-18
• Model Number: *
• Catalog Number: *
• Lot Number: M601001
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 750410
• Manufacturer: BECKMAN COULTER
• Manufacturer Address: 200 S. KRAEMER BLVD P.O. BOX 8000 BREA CA * US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2006-09-18