MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT G3+ CARTRIDGE

Catalog Number	03P78-50
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/14/2017
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 05/11/2017.Retain and return product was tested and performing to specification.Investigation: a review of the device history record confirmed the lot passed finished goods release criteria.Retain cartridge testing met the acceptance criteria found in q04.01.003 rev.Z, appendix 1 - product complaint level 2 and level 3 investigation procedure.Assessment: the complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.Based on the i-stat ph results of 7.299 and 7.333 and i-stat pco2 results of 8.8 and 45 mm hg there is an indication an i-stat product malfunction occurred.The oxygen values are within the total allowable error (greater of 5 mm hg or 10%) and the calculated so2 is within 1%.
Event or Problem Description
On (b)(6) 2017, abbott point of care was contacted by a customer regarding i-stat g3+ cartridges that yielded suspected discrepant ph, pco2, po2, tco2, be, so2, and hco3 results on a (b)(6) female patient with a shoulder injury.No additional patient information was available.(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-STAT G3+ CARTRIDGE
• Common Device Name: G3+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 6941391
• Report Number: 2245578-2017-00568
• Device Sequence Number: 16345627
• Product Code: CHL
• UDI-Device Identifier: 10054749000064
• UDI-Public: 10054749000064
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K940918
• 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: Health Professional
• Device Expiration Date: 07/14/2017
• Device Catalogue Number: 03P78-50
• Device Lot Number: D16322A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• 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: 63 YR