SICKLESCREEN SICKLING HB SCREENING KIT 10-0250, 10-0258

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-11-22 for SICKLESCREEN SICKLING HB SCREENING KIT 10-0250, 10-0258 manufactured by Pacific Hemostasis.

Event Text Entries

[17112038] On 10/25/96, two distinct hosp labs reported that 30 determination hemoglobin screening kit lot 250a03 (referred to as device 1) was producing false negative results with positive pt specimens.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1055411-1996-00001
• MDR Report Key: 53215
• Report Source: 05,06
• Date Received: 1996-11-22
• Date of Report: 1996-11-21
• Date of Event: 1996-10-25
• Date Mfgr Received: 1996-10-25
• Device Manufacturer Date: 1996-10-01
• Date Added to Maude: 1996-12-05
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 3
• Remedial Action: RL
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SICKLESCREEN SICKLING HB SCREENING KIT
• Generic Name: IN VITRO DIAGNOSTIC TEST KIT - QUALITATIVE
• Product Code: GHM
• Date Received: 1996-11-22
• Model Number: NA
• Catalog Number: 10-0250, 10-0258
• Lot Number: 250A03, 258A04
• ID Number: FISHER CAT# 22251050,23262375
• Device Expiration Date: 1998-09-30
• Operator: OTHER
• Device Availability: Y
• Device Age: *
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 53833
• Manufacturer: PACIFIC HEMOSTASIS
• Manufacturer Address: 11515 VANSTORY DRIVE HUNTERSVILLE SC 28078 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1996-11-22