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	05/17/2017
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 09/26/2016.Retain product was tested and functioning according to specification.Return product was not available.Investigation: a review of the device history record confirmed the cartridge lot passed finished goods release criteria.Twenty retained cartridges from g3+ lot d16037 were tested using whole blood.The customer observation of po2 star-out results, discrepant pco2 or results related to discrepant bicarbonate results were not reproduced.The results of testing met the acceptance criteria found in q04.01.003 rev.Y, appendix 1- product complaint level 2 and level 3 investigation procedure.The investigation confirmed the cartridge lots are performing to specification.No deficiency identified.Assessment: the complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.Hco3 is a calculated value based on the measured ph and pco2 (log hco3 = ph + log pco2 - 7.608).There are no repeats on any sample.Samples 1, 4 and 7 are consistent for ph, pco2 and po2 and samples 2,3 5 and 6 are consistent for ph, pco2 and po2.It was unknown if there were bubbles in any of the samples.
Event or Problem Description
On (b)(6) 2015, abbott point of care was contacted by a customer regarding i-stat g3+ cartridges that yielded suspected discrepant pco2 results on a patient.There was no additional patient information at the time of this report.Return product is not available for investigation.(b)(6).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: 6938645
• Report Number: 2245578-2017-00540
• Device Sequence Number: 13725600
• Product Code: CHL
• UDI-Device Identifier: 10054749000064
• UDI-Public: 10054749000064
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: 09/28/2016
• Device Catalogue Number: 03P78-50
• Device Lot Number: D16037
• 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
• Patient Age: 21 DA