ACCEAVA HCG URINE TEST HCG BASIC 50 TEST

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-08 for ACCEAVA HCG URINE TEST HCG BASIC 50 TEST manufactured by Thermo Biostar.

Event Text Entries

[312263] Control line (pink line) is very faint when performing pregnancy testing. The inner tube containing test strips had different lot # from the lot # on outer box. Reporter's running 2-3 tests per pt to ensure accuracy of tests. It is very difficult to determine results with such faint error readings.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1033549
• MDR Report Key: 556395
• Date Received: 2004-09-23
• Date of Event: 2004-09-08
• Date Added to Maude: 2004-11-26
• 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
• 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: ACCEAVA HCG URINE TEST
• Generic Name: PREGNANCY TEST
• Product Code: JHJ
• Date Received: 2004-09-08
• Model Number: HCG BASIC
• Catalog Number: 50 TEST
• Lot Number: 017993
• ID Number: *
• Device Expiration Date: 2004-11-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 546064
• Manufacturer: THERMO BIOSTAR
• Manufacturer Address: * LOUISVILLE CO * US

Device Sequence Number: 2

• Brand Name: ACCEAVA HCG URINE TEST
• Generic Name: PREGNANCY TEST
• Product Code: JHJ
• Date Received: 2004-09-08
• Model Number: HCG BASIC
• Catalog Number: 50 TEST
• Lot Number: 011032
• ID Number: *
• Device Expiration Date: 2005-01-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 546192
• Manufacturer: THERMO BIOSTAR
• Manufacturer Address: * LOUISVILLE CO * US

Device Sequence Number: 3

• Brand Name: ACCEAVA HCG URINE TEST
• Generic Name: PREGNANCY TEST
• Product Code: JHJ
• Date Received: 2004-09-08
• Model Number: HCG BASIC
• Catalog Number: 50 TEST
• Lot Number: 017974
• ID Number: *
• Device Expiration Date: 2004-10-01
• Operator: HEALTH PROFESSIONAL
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 546196
• Manufacturer: THERMO BIOSTAR
• Manufacturer Address: * LOUISVILLE CO * US

Device Sequence Number: 4

• Brand Name: ACCEAVA HCG URINE TEST
• Generic Name: PREGNANCY TEST
• Product Code: JHJ
• Date Received: 2004-09-08
• Model Number: HCG BASIC
• Catalog Number: 50 TEST
• Lot Number: 017893
• ID Number: *
• Device Expiration Date: 2004-07-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 546197
• Manufacturer: THERMO BIOSTAR
• Manufacturer Address: * LOUISVILLE CO * US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-09-23