PACIFIC HEMOSTASIS * 100356

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-30 for PACIFIC HEMOSTASIS * 100356 manufactured by Fisher Diagnostics.

Event Text Entries

[15380445] Evidence showed the current lot number of pacific hemostasis thromboplastin-d reagent was number 357-104 with an expiration date of august 2004. The package test insert stated that "thromboplastin-d is suitable for use with manual, mechanical, photo-optical, or other means of clot detection. Follow manufacturer's recommendations for proper use of instrumentation". The isi for a mechanical instrument was listed on the side of the box as 1. 84, and for a photo-optical instrument as 1. 92. The package test insert also stated "for additional instrument isi values, call pacific hemostasis". The coagulation instrument in use in this lab is an acl-1000, which is a nephelometric in a nephelometric instrument. The pt normal mean established by the general supervisor for the lab was 9. 9 seconds. The average value of a normal population for all instruments combined -not including the acl-1000- ranged from 11. 3 to 12. 2 seconds. The surveyor questioned the low pt normal mean in this lab. December an inspector called a technical rep from pacific hemostasis concerning the low mean. The tech rep stated thromboplastin-d was not recommended for nephelometric methods and the isi not established by the manufacturer. The tech rep stated that nephelometric methodologies, such as employed by the acl-1000, require use of thromboplastin-dl with an isi ranging from 1. 7 to 2. 0 to achieve a rep pt normal mean. The tech rep stated that all sales reps had been informed of this. -the package test insert did not list this thromboplastin in its ordering info. The inspector notified the general supervisor to call pacific hemostasis. The general supervisor stated the lab had received a new lot of reagent and was ready to evaluate it. After the call to pacific hemostasis, the lab began sending prothrombin time tests to another hosp for testing. After the lab received the correct reagent and notified the surveyor that they had evaluated it, the new pt mean was 11. 0.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1030727
• MDR Report Key: 505877
• Date Received: 2003-12-30
• Date of Report: 2003-12-30
• Date Added to Maude: 2004-01-14
• 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
• 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: PACIFIC HEMOSTASIS
• Generic Name: THROMBOPLASTIN-D REAGENT FOR PERFORMANCE OF PTS
• Product Code: GGO
• Date Received: 2003-12-30
• Model Number: *
• Catalog Number: 100356
• Lot Number: 357-104
• ID Number: *
• Device Expiration Date: 2004-08-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 494746
• Manufacturer: FISHER DIAGNOSTICS
• Manufacturer Address: 8365 VALLEY PIKE MIDDLETOWN VA 22645 US

Device Sequence Number: 2

• Brand Name: PACIFIC HEMOSTASIS
• Generic Name: THROMBOPLASTIN-D REAGENT FOR PERFORMANCE OF PTS
• Product Code: GGO
• Date Received: 2003-12-30
• Model Number: *
• Catalog Number: 100357
• Lot Number: 357-104
• ID Number: *
• Device Expiration Date: 2004-08-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 494747
• Manufacturer: FISHER DIAGNOSTICS
• Manufacturer Address: 8365 VALLEY PIKE MIDDLETOWN VA 22645 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-12-30