MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT EG7+ CARTRIDGE

Catalog Number 03P76-25

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Code Available (3191)

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On (b)(6) 2020, abbott point of care was contacted by a customer regarding i-stat eg7+ cartridges that yielded suspected discrepant ionized calcium results of >2.5 on a (b)(6) year old female patient with a coronary artery blockage who underwent a coronary artery bypass graft.The patient was admitted on (b)(6) 2020 and had not been discharged at the time of the call.There was no patient information available at the time of this report.Return product is available for investigation.(b)(6).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.

Manufacturer Narrative

Apoc incident #: (b)(4).The investigation was completed on 05/06/2020.A review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Retained testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ae (product complaint level 2 and level 3 investigation procedure).No deficiency has been determined for eg7+ lot n20003b.

• Brand Name: I-STAT EG7+ CARTRIDGE
• Type of Device: EG7+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton, nj
• MDR Report Key: 9982177
• MDR Text Key: 198919485
• Report Number: 2245578-2020-00048
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 10054749000040
• UDI-Public: 10054749000040
• Combination Product (y/n): N
• PMA/PMN Number: K940918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: 03P76-25
• Device Lot Number: N20003B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR