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	Lethargy (2560)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On (b)(6) 2019, abbott point of care was contacted by a customer regarding i-stat g3+ cartridges that yielded a suspected discrepant ph, pco2, and hc03 on a (b)(6) male patient that was presented lethargic.There was no additional patient information available at the time of this report.Return product is not available for investigation.(b)(6).At this time there is no reason to suspect a malfunction exists.The customer stated that ph, pco2, and hc03 results are unexpected.However, the ph result of 7.228 mmhg appeared to be the discrepant result and potentially related to sample handling although not confirmed at this time.The reporting decision was based on limited information available that suggests the product was not performing within the variability of the assay.
Additional Manufacturer Narrative
Apoc incident # (b)(4).The investigation was completed on 05/07/2019.A review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Retained testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ad (product complaint level 2 and level 3 investigation procedure).No deficiency has been determined for g3+ lot d18274b.

• 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: 8435832
• Report Number: 2245578-2019-00063
• Device Sequence Number: 2052044
• Product Code: CHL
• UDI-Device Identifier: 10054749002280
• UDI-Public: 10054749002280
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 05/10/2019

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: 05/31/2019
• Device Catalogue Number: 03P78-50
• Device Lot Number: D18274B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR