SYSMEX CA-1000 B4260-1000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-11-17 for SYSMEX CA-1000 B4260-1000 manufactured by Toa Medical Electronics.

Event Text Entries

[16300008] Discordant pt results were obtained when testing a specimen using analyzer. Discordant prothrombin time (pt=134 sec) result with a good curve was obtained on the initial specimen. This specimen tested against a reference method yielded a pt result of 42 seconds. Subsequent specimen tested on the device yielded a pt result of 32. 1 seconds. Controls were within range. Results on the device analyzer were not reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1017272-1995-00002
• MDR Report Key: 28784
• Date Received: 1995-11-17
• Date of Report: 1995-11-15
• Date of Event: 1995-11-03
• Date Facility Aware: 1995-11-03
• Report Date: 1995-11-15
• Date Reported to FDA: 1995-11-15
• Date Reported to Mfgr: 1995-11-15
• Date Added to Maude: 1995-12-19
• 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: 0
• Reporter Occupation: MEDICAL TECHNOLOGIST
• 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: SYSMEX CA-1000
• Generic Name: COAGULATION ANALYZER
• Product Code: KQG
• Date Received: 1995-11-17
• Model Number: CA-1000
• Catalog Number: B4260-1000
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 29751
• Manufacturer: TOA MEDICAL ELECTRONICS
• Manufacturer Address: 4-4-4 TAKATSUKADAI NISHI-KU, KOBE JA 65122

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1995-11-17