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

Catalog Number	03P82-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Cataract (1766)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On (b)(6) 2020, abbott point of care was contacted by a customer regarding i-stat e3+ cartridges that yielded a suspected discrepant hematocrit results of <15 % pcv on a (b)(6) year old male patient.There was no additional patient information available at the time of this report.Return product is available for investigation.(b)(6).Test and collection times not provided.Per i-stat system manual art: (b)(4): this result is dependent on another test that has been flagged (< >).If a sodium result is displayed as >180, the calculations for potassium, chloride, bun/urea and hematocrit, which depend upon the sodium measurement, will be flagged < >.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on limited information available that suggests the product was not performing within the variability of the assay.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident # (b)(6).The investigation was completed on (b)(6) 2020.A review of the device history record confirmed the lot passed finished goods release criteria.Retained cartridge testing met the acceptance criteria found in q04.01.003 rev.Ad, appendix 1- product complaint level 2 and level 3 investigation procedure.Returned cartridge testing met the acceptance criterion for suppressed results but the sample size was too small to assess points outside total allowable error (ea).No deficiency has been identified.
Event or Problem Description
Na.

• 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: 9642594
• Report Number: 2245578-2020-00021
• Device Sequence Number: 2898059
• Product Code: JGS
• UDI-Device Identifier: 10054749000101
• UDI-Public: 10054749000101
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2020
• Device Catalogue Number: 03P82-25
• Device Lot Number: J19189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR