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

Catalog Number	03P78-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (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 gave star outs for po2 and so2, suppressed results for be, hco3, tco2 and so2.There was no additional patient information available at the time of this report.Return product is not available for investigation.On (b)(6) 2020 the customer reported discrepant results along with the data.(b)(6).At this time there is no reason to suspect a malfunction exists.On (b)(6) 2020 the customer provided results associated with ph, pco2, and po2 that were unexpected.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 07/28/2020.A review of the device history record (dhr) confirmed the lot passed finished goods release criteria.Retain cartridge testing met the acceptance criteria as outlined in appendix 1 of q04.01.003 rev af (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified for cartridge lot n19280.
Event or Problem Description
Na.

• Brand Name: I-STAT G3+ CARTRIDGE
• Common Device Name: G3+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton, nj
• MDR Report Key: 10138318
• Report Number: 2245578-2020-00060
• Device Sequence Number: 13903365
• Product Code: CHL
• UDI-Device Identifier: 10054749000064
• UDI-Public: 10054749000064
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 07/28/2020

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: 06/05/2020
• Device Catalogue Number: 03P78-25
• Device Lot Number: N19280
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1