I-STAT B-HCG CARTRIDGE 05P58-25

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-08 for I-STAT B-HCG CARTRIDGE 05P58-25 manufactured by Abbott Point Of Care.

MAUDE Entry Details

• Report Number: 2245578-2020-00004
• MDR Report Key: 9563932
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2020-01-08
• Date of Report: 2020-01-13
• Date of Event: 2019-12-30
• Date Mfgr Received: 2020-01-09
• Device Manufacturer Date: 2019-09-28
• Date Added to Maude: 2020-01-08
• 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: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: LINDA MACZUSZENKO
• Manufacturer Street: 400 COLLEGE ROAD
• Manufacturer City: PRINCETON NJ 08540
• Manufacturer Country: US
• Manufacturer Postal: 08540
• Manufacturer Phone: 6136885949
• Manufacturer G1: ABBOTT POINT OF CARE CANADA LTD.
• Manufacturer Street: 185 CORKSTOWN ROAD
• Manufacturer City: K2H 8V4
• Manufacturer Country: CA
• Manufacturer Postal Code: K2H 8V4
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: I-STAT B-HCG CARTRIDGE
• Generic Name: B-HCG CARTRIDGE
• Product Code: DHA
• Date Received: 2020-01-08
• Model Number: NA
• Catalog Number: 05P58-25
• Lot Number: N19271A
• Device Expiration Date: 2020-03-13
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ABBOTT POINT OF CARE
• Manufacturer Address: 400 COLLEGE ROAD PRINCETON NJ 085406607 US 085406607

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-08