MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CG8+ CARTRIDGE

Catalog Number 03P88-25

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

Patient Problems Anemia (1706); Respiratory Distress (2045); Alteration In Body Temperature (2682)

Event Date 03/05/2020

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 cg8+ cartridges that yielded suspected discrepant hematocrit result of 47% on a (b)(6) year old female patient with enzyme disorder (fumarase deficiency); impaired regulation of body temperature; chronic respiratory insufficiency; anemia.There was no additional patient information available at the time of this report.Return product is available for investigation.Method: sysmex, date: (b)(6) 2020, collected: 20:44, tested: 21:47, hematocrit: 11.3%.I-stat, (b)(6) 2020, 20:45, 20:48, 47.0%.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.There were multiple attempts for information but to no avail.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 04/09/2020.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).The customer complaint was not reproduced in returned testing.No deficiency has been determined for cg8+ lot w20040.

Event Description

Na.

• Brand Name: I-STAT CG8+ CARTRIDGE
• Type of Device: CG8+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton, nj
• MDR Report Key: 9850209
• MDR Text Key: 198917139
• Report Number: 2245578-2020-00037
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 10054749000163
• UDI-Public: 10054749000163
• 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: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2020
• Device Catalogue Number: 03P88-25
• Device Lot Number: W20040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 13 YR