MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT EC4+CARTRIDGE; EC4+ CARTRIDGE

Catalog Number	03P81-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 04/05/2016.Retain product was tested and functioning according to specification.Investigation: the device history record (dhr) for this lot was reviewed.The lot passed finished goods (fg) release criteria.Forty retained cartridges from the lot were tested using a whole blood (wb) and a low hct blood sample.The compliant was not reproduced.Testing met the acceptance criteria found in q04.01.003 rev.X, appendix 1 - product complaint level 2 and level 3 investigation procedure.Three hundred returned cartridges from the lot were tested using wb and low hct blood samples and i-stat level 1 control (l1).The complaint was not reproduced.Testing met the acceptance criteria found in q04.01.003 rev.X, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.Assessment: the complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.The samples were contrived for use in an internal apoc verification study.Patient results inside the ler zone pose a risk to patient safety.When values fall inside the ler zones, potential harm can occur to the patients if these results are utilized in medical decision-making.The ler established for the i-stat sodium assay is 18 mm up to 146 mm and 14 mm after that.
Event or Problem Description
On (b)(6) 2015, abbott point of care was contacted by a customer regarding i-stat ec4+ cartridges that yielded suspected discrepant hct results.The issue occured internally during verification.There was no patient testing performed.(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)(6)).

• Brand Name: I-STAT EC4+CARTRIDGE
• Common Device Name: EC4+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 6938668
• Report Number: 2245578-2017-00535
• Device Sequence Number: 19193448
• Product Code: JGS
• UDI-Device Identifier: 10054749000095
• UDI-Public: 10054749000095
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K912387
• 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: 06/14/2016
• Device Catalogue Number: 03P81-25
• Device Lot Number: K15273
• 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