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	No Information (3190)
Date of Event	06/17/2017
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 10/12/2016.Retain product was tested and functioning according to specification.Return product was not available.Investigation: a review of the device history record confirmed the lot passed finished goods release criteria.Retained cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Y (product complaint level 2 and level 3 investigation procedure).Assessment: the complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.There were no repeats on the same sample.
Event or Problem Description
On (b)(6) 2016, abbott point of care was contacted by a customer regarding i-stat g3+ cartridges that yielded suspected discrepant pco2 (high), po2 and so2 (low) results on a patient.There was no additional patient information at the time of this report.Return product is not available for investigation.So2 result was 19 ref.Range is 95-98.Po2 result was 18 ref.Range is 80-105.Pco2 result was 85.8 ref.Range is 35-45.Caller mentioned the patient has been retaining high levels of co2.Two results were 33 and 35.The customer stated that they repeated the test with a fresh sample and the pco2 was 73.9 mmhg which is still critically high, po2 was 66 which is low and so2 89 which is also low.At the time of the event there was no indication of a product malfunction based on the information provided and assessed by apoc, however this mdr is a retrospective filing in response to an observation from an fda inspection conducted may 8th to 12th, 2017 at abbott point of care ((b)(4).

• 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: 6938657
• Report Number: 2245578-2017-00541
• Device Sequence Number: 1364678
• Product Code: CHL
• UDI-Device Identifier: 10054749000064
• UDI-Public: 10054749000064
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/10/2017

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: 06/28/2016
• Device Catalogue Number: 03P78-50
• Device Lot Number: D15315A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1