CHOLESTECH LDX 05625 10-004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-11 for CHOLESTECH LDX 05625 10-004 manufactured by Cholestech Corp..

Event Text Entries

[15681368] Cholesterol cassette - no reaction would occur. Cholesterol high and low controls were out of range.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1021594
• MDR Report Key: 326760
• Date Received: 2001-04-11
• Date of Report: 2001-04-05
• Date of Event: 2000-11-01
• Date Added to Maude: 2001-04-17
• 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 Sequence Number: 1

• Brand Name: CHOLESTECH LDX
• Generic Name: ANALYZER-CHOLESTEROL AND GLUCOSE
• Product Code: JGY
• Date Received: 2001-04-11
• Returned To Mfg: 2001-03-01
• Model Number: 05625
• Catalog Number: 10-004
• Lot Number: C08 3108 - 7 BOXES
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 316163
• Manufacturer: CHOLESTECH CORP.
• Manufacturer Address: 3347 INVESTMENT BLVD HAYWARD CA 94545 US

Device Sequence Number: 2

• Brand Name: CHOLESTECH LDX
• Generic Name: ANALYZER - CHOLESTEROL & GLUCOSE
• Product Code: JGY
• Date Received: 2001-04-11
• Returned To Mfg: 2001-03-01
• Model Number: *
• Catalog Number: 10-004
• Lot Number: C04 3211 - 22 BOXES
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 316302
• Manufacturer: CHOLESTECH CORP
• Manufacturer Address: 3347 INVESTMENT BLVD HAYWARD CA 94545 US

Device Sequence Number: 3

• Brand Name: CHOLESTECH LDX
• Generic Name: ANALYZER - CHOLESTEROL & GLUCOSE
• Product Code: JGY
• Date Received: 2001-04-11
• Returned To Mfg: 2001-03-01
• Model Number: *
• Catalog Number: 10-004
• Lot Number: C11 3208 - 27 BOXES
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 316303
• Manufacturer: CHOLESTECH CORP.
• Manufacturer Address: 3347 INVESTMENT BLVD HAYWARD CA 94545 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-04-11