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	Asthma (1726)
Date of Event	10/24/2020
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 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.
Additional 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
• Common Device Name: G3+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 10779245
• Report Number: 2245578-2020-00115
• Device Sequence Number: 14299125
• Product Code: CHL
• UDI-Device Identifier: 10054749002280
• UDI-Public: 10054749002280
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K940918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 12/02/2020
• 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