AIA-600 II 019328

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-10-28 for AIA-600 II 019328 manufactured by Tosoh Corp..

Event Text Entries

[312239] Customer reported discrepancy on one ckmb result. Customer initially reported a high ckmb result on a pt. Another draw 1 hour later gave a normal ckmb result. Repeat of both specimens gave high results.
Patient Sequence No: 1, Text Type: D, B5

[312797] Customer reported discrepancy on one ckmb result. Customer initially reported a high ckmb result on a pt. Another draw 1 hour later gave a normal ckmb result. Repeat of both specimens gave high results.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2950409-2004-00014
• MDR Report Key: 553323
• Date Received: 2004-10-28
• Date of Report: 2004-10-28
• Date of Event: 2004-02-17
• Date Facility Aware: 2004-02-17
• Report Date: 2004-10-28
• Date Reported to FDA: 2004-10-28
• Date Reported to Mfgr: 2004-10-28
• Date Added to Maude: 2004-11-05
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• 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: AIA-600 II
• Generic Name: ENZYME IMMUNOASSAY ANALYZER
• Product Code: JHY
• Date Received: 2004-10-28
• Model Number: 600 II
• Catalog Number: 019328
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 4 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 542912
• Manufacturer: TOSOH CORP.
• Manufacturer Address: * TOKYO JA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-10-28