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

Catalog Number 03P78-50

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Asthma (1726)

Event Date 10/24/2020

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On 26-oct-2020, abbott point of care was contacted by a customer regarding i-stat g3+ cartridges that yielded a suspected discrepant pco2 result of 9.5 mmhg on a (b)(6) year old male with asthma.There was no additional patient information available at the time of this report.Return product is not available for investigation.Method: date: tested: ph: pco2: po2: be,b: hco3: tco2: so2: fio2; i-stat (b)(6) 2020 16:12 7.247 9.5mmhg 94mmhg 20 4.1mmol/l <5mmol/l 96% 36; i-stat (b)(6) 2020 16:12 7.254 63.1mmhg 103mmhg 1 27.9mmol/l 30 mmol/l 97% n/a.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on limited information available that suggests the product was not performing within the variability of the assay.The investigation is underway.

Manufacturer Narrative

Apoc incident: (b)(4).The investigation was completed on 25-nov-2020.A review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Retained testing met the acceptance criteria found in q04.01.003 rev.Af, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been determined for g3+ lot d20154.

• Brand Name: I-STAT G3+ CARTRIDGE
• Type of Device: G3+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 10779245
• MDR Text Key: 249658925
• Report Number: 2245578-2020-00115
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 10054749002280
• UDI-Public: 10054749002280
• Combination Product (y/n): N
• PMA/PMN Number: K940918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 03P78-50
• Device Lot Number: D20154
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR