MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT E3+CARTRIDGE; E3+ CARTRIDGE

Catalog Number	03P82-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Weakness (2145); Dizziness (2194)
Date of Event	07/10/2015
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 09/08/2016.Retain and return product were tested and functioning according to specification.Investigation: a review of the device history record confirmed the lot passed finished goods release criteria.20 retained cartridges were tested in whole blood.The customer complaint was not reproduced.Test results for the cartridges met the acceptance criteria found in q04.01.003 rev.V, appendix 1- product complaint level 2 and level 3 investigation procedure.Twentyfive (25) returned cartridges were tested in whole blood.The customer complaint was not reproduced.Test results for the cartridges met the acceptance criteria found in q04.01.003 rev.V, appendix 1- product complaint level 2 and level 3 investigation procedure.The investigation confirms the lot is performing to specification.No deficiency was identified.Assessment: there are no repeats on i-stat or the laboratory.Two different samples were tested on the two systems and handled in different ways.The i-stat hct is affected by white blood cell count, lipids and total protein as well as any interfering factor that may impact the i-stat sodium test.Erroneous hematocrit results can be obtained by improper sample handling.Hematocrit results can be affected by the settling of red blood cells in the collection device.The best way to avoid the affect of settling is to test the sample immediately.If there is a delay in testing of a minute or more, the sample must be remixed thoroughly.The complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.
Event or Problem Description
On (b)(6) 2015, abbott point of care was contacted by a customer regarding i-stat e3+ cartridges that yielded suspected discrepant hct and hgb results on a patient admitted for complications associated with crohn's disease.Gi bleeding, weakness/dizziness, diarrhea.There was no additional patient information available at the time of this report.Return product is available for investigation.I-stat hct 43, i-stat sample collected and run immediately on the istat after draw, i-stat sample resulted at 19:55.Istat hgb 14.6.Sysmex hct 21, sysmex sample collected at 19:40, sysmex sample resulted at 1945 sysmex hgb 7.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 E3+CARTRIDGE
• Common Device Name: E3+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 6941673
• Report Number: 2245578-2017-00534
• Device Sequence Number: 873308
• Product Code: JGS
• UDI-Device Identifier: 10054749000101
• UDI-Public: 10054749000101
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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): 10/11/2017

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: 12/28/2015
• Device Catalogue Number: 03P82-25
• Device Lot Number: J15011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• 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: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1