MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CREA CARTRIDGE

Catalog Number 03P84-25

Device Problem False Positive Result (1227)

Patient Problem Breast Mass (2439)

Event Date 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On (b)(6) 2017, abbott point of care was contacted by a customer regarding i-stat crea cartridges that yielded a suspected discrepant result of 2.3 on a (b)(6) female patient.There was no additional patient information at the time of this report.The customer states that return product is not available for investigation.Date: (b)(6) 2017, sample: a, collected: 11:40, tested: 11:53, result: 2.3; (b)(6) 2017, a, 11:40, 12:21, 0.7.There are no injuries associated with this event.The investigation is underway.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 04/19/2017.Retain product was tested and functioning according to specification.Return product was not available for investigation.

• Brand Name: I-STAT CREA CARTRIDGE
• Type of Device: CREA CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; ottawa, ontario K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 6412582
• MDR Text Key: 70427793
• Report Number: 2245578-2017-00011
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 10054749000125
• UDI-Public: (01)10054749000125(17)170528(10)A16339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• Device Catalogue Number: 03P84-25
• Device Lot Number: A16339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 03/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR