MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT 6+ CARTRIDGE

Catalog Number	03P80-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident (b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 08/30/2017.Retain and return product was tested and functioning according to specification.Investigation: a review of the device history record confirmed the lot passed finished goods release criteria.Retain and return testing met the acceptance criteria found in q04.01.003 rev.Aa appendix 1- product complaint level 2 and level 3 investigation procedure.Assessment: no repeats on either system and different samples were tested approximately 4 hours apart.The complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.There is not enough information to determine whether an i-stat product malfunction occurred.
Event or Problem Description
On (b)(6)2017, abbott point of care was contacted by a customer regarding i-stat 6+ cartridges that yielded suspected discrepant hematocrit and hemoglobin results on a patient admitted for examination of the cardiovascular system prior to surgery.The patient appeared pale.There was additional no patient information available at the time of this report.Return product is available for investigation.Method: i-stat, collected:18:06 tested: 18:08 sample:unk hb:12.2 hct: 36.0 sample:1.Sysmex, 20:33, 21:52, venous, 6.9, 21.6, 2.Samples were collected and tested on (b)(6) 2017.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-STAT 6+ CARTRIDGE
• Common Device Name: 6+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 6941649
• Report Number: 2245578-2017-00580
• Device Sequence Number: 16356504
• Product Code: JGS
• UDI-Device Identifier: 10054749000088
• UDI-Public: 10054749000088
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K912387
• 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): 10/11/2017

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: No Information
• Device Expiration Date: 10/14/2017
• Device Catalogue Number: 03P80-25
• Device Lot Number: K17020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• 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: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR