HYBRITECH ICON II HCG * 4135

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-03-09 for HYBRITECH ICON II HCG * 4135 manufactured by Hybritech Corp..

Event Text Entries

[18447919] Pregnancy test kit giving all positive results. After lab mgr called the co, there was a possibility that the reagents were contaminated.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	269432
MDR Report Key	269432
Date Received	2000-03-09
Date of Report	2000-03-08
Date of Event	1999-12-06
Date Facility Aware	1999-12-26
Report Date	2000-03-08
Date Reported to FDA	2000-03-08
Date Added to Maude	2000-03-17
Event Key	0
Report Source Code	User Facility 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	RISK MANAGER
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 Sequence Number: 1

Brand Name	HYBRITECH ICON II HCG
Generic Name	PREGNANCY TEST KIT
Product Code	LCY
Date Received	2000-03-09
Returned To Mfg	1999-12-01
Model Number	*
Catalog Number	4135
Lot Number	990603
ID Number	*
Device Expiration Date	2000-02-17
Operator	HEALTH PROFESSIONAL
Device Availability	R
Device Age	UNKNOWN
Implant Flag	N
Date Removed	A
Device Sequence No	1
Device Event Key	260840
Manufacturer	HYBRITECH CORP.
Manufacturer Address	* SAN DIEGO CA 92121 US

Device Sequence Number: 2

Brand Name	HYBRITECH ICON II HCG
Generic Name	REAGENT A
Product Code	LCY
Date Received	2000-03-09
Returned To Mfg	1999-12-01
Model Number	*
Catalog Number	4135
Lot Number	960455
ID Number	*
Device Expiration Date	2000-02-17
Operator	HEALTH PROFESSIONAL
Device Availability	R
Device Age	UNKNOWN
Implant Flag	N
Date Removed	A
Device Sequence No	2
Device Event Key	260841
Manufacturer	HYBRITECH CORP.
Manufacturer Address	* SAN DIEGO CA 92121 US

Device Sequence Number: 3

Brand Name	HYBRITECH ICON II HCG
Generic Name	REAGENT B
Product Code	LCY
Date Received	2000-03-09
Returned To Mfg	1999-12-01
Model Number	*
Catalog Number	4135
Lot Number	960460A
ID Number	*
Device Expiration Date	2000-02-17
Operator	HEALTH PROFESSIONAL
Device Availability	R
Device Age	UNKNOWN
Implant Flag	N
Date Removed	A
Device Sequence No	3
Device Event Key	260843
Manufacturer	HYBRITECH CORP.
Manufacturer Address	* SAN DIEGO CA 92121 US

Device Sequence Number: 4

Brand Name	HYBRITECH ICON II HCG
Generic Name	REAGENT C
Product Code	LCY
Date Received	2000-03-09
Returned To Mfg	1999-12-01
Model Number	*
Catalog Number	4135
Lot Number	960611
ID Number	*
Device Expiration Date	2000-02-17
Operator	HEALTH PROFESSIONAL
Device Availability	R
Device Age	UNKNOWN
Implant Flag	N
Date Removed	A
Device Sequence No	4
Device Event Key	260845
Manufacturer	HYBRITECH CORP.
Manufacturer Address	* SAN DIEGO CA 92121 US

Device Sequence Number: 5

Brand Name	HYBRITECH ICON II HCG
Generic Name	DILUENT
Product Code	LCY
Date Received	2000-03-09
Returned To Mfg	1999-12-01
Model Number	*
Catalog Number	4135
Lot Number	960459
ID Number	*
Device Expiration Date	2000-02-17
Operator	HEALTH PROFESSIONAL
Device Availability	R
Device Age	UNKNOWN
Implant Flag	N
Date Removed	A
Device Sequence No	5
Device Event Key	260846
Manufacturer	HYBRITECH CORP.
Manufacturer Address	* SAN DIEGO CA 92121 US

Device Sequence Number: 6

Brand Name	HYBRITECH ICON II HCG
Generic Name	CYLINDERS
Product Code	LCY
Date Received	2000-03-09
Returned To Mfg	1999-12-01
Model Number	*
Catalog Number	4135
Lot Number	960469C
ID Number	*
Device Expiration Date	2000-02-17
Operator	HEALTH PROFESSIONAL
Device Availability	R
Device Age	UNKNOWN
Implant Flag	N
Date Removed	A
Device Sequence No	6
Device Event Key	260847
Manufacturer	HYBRITECH CORP.
Manufacturer Address	* SAN DIEGO CA 92121 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2000-03-09