MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT1 ANALYZER, IMMUNO READY

Catalog Number	06F16-10
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 10/05/2016.The analyzer was tested and found to be functioning according to specification.Investigation: the device history record for this analyzer was reviewed.The analyzer passed finished goods release criteria.Fifty pt/inr cartridges were tested using level 1 and level 2 controls, and all results were within the acceptance range.The complaint was not reproduced.Assessment: the complaint investigation concluded there was no product deficiency and that the i-stat analyzer is meeting specification.
Event or Problem Description
On (b)(6) 2016, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded unexpected results on a patient.There was no additional patient information available at the time of this report.(b)(6).At the time of the event there was no indication of a product malfunction based on the information provided and assessed by apoc; however, this mdr is a retrospective filing in response to an observation from an fda inspection conducted may 8th to 12th, 2017 at abbott point of care (b)(4).

• Brand Name: I-STAT1 ANALYZER, IMMUNO READY
• Common Device Name: I-STAT1 ANALYZER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 6932451
• Report Number: 2245578-2017-00399
• Device Sequence Number: 13720917
• Product Code: CGA
• UDI-Device Identifier: 00054749000340
• UDI-Public: (01)00054749000340
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K001387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 06F16-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1