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 Codes	High Blood Pressure/ Hypertension (1908); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 12/07/20108.A review of the device history record confirmed the lot passed finished goods release criteria.Retain and returned cartridge test results met the acceptance criteria found in q04.01.003 rev.Ac, appendix 1- product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.
Event or Problem Description
On 11/26/2018, abbott point of care was contacted by a customer regarding i-stat g3+ cartridges that yielded a suspected discrepant po2 result of 41mmhg on a (b)(6) year old male patient with diabetes and hypertension.The customer repeated the test using another lot and results were as expected.There was no additional patient information available at the time of this report.Return product is available for investigation.Method; date; collected; tested; po2; sample: i-stat (b)(6) 2018, 0505, 0511, 41 mmhg, a; i-stat (b)(6) 2018, 0505, 051,1 72 mmhg, a.Ref range 80-100 mmhg.At this time there is no reason to suspect a malfunction exists.The customer stated that only po2 results are unexpected, and ph results are acceptable.However, the issue appears to be related to sample handling although not confirmed at this time.The reporting decision was based on information available that suggests the product was not performing within the variability of the assay.

• 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: 8156745
• Report Number: 2245578-2018-00316
• Device Sequence Number: 252517
• Product Code: CHL
• UDI-Device Identifier: 10054749002280
• UDI-Public: 10054749002280
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 12/12/2018

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: 05/02/2019
• Device Catalogue Number: 03P78-50
• Device Lot Number: D18245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR