MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CG4+ CARTRIDGE

Catalog Number 03P85-50

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

Patient Problem No Information (3190)

Event Date 07/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional cartridge lot information: lot#: : d18129, mfg date: 05/09/2018, expiration date: 01/06/2019.Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On (b)(6) 2018, abbott point of care was contacted by a customer regarding i-stat cg4+ cartridges (lot# d18176a and d18129) that yielded suspected discrepant lactate results on an (b)(6) female auto trauma patient.There was no additional patient information available at the time of this report.Return product is available.(b)(6).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 the limited information available that suggests the product was not performing within the variability of the assay.Both i-stat lots are consistent with each other and there was no repeat on the lab instrument.The investigation is underway.

Event Description

Na.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 09/27/2018.A review of the device history records (dhrs) confirmed the cartridge lots met finished goods (fg) release criteria.Retained cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ac (product complaint level 2 and level 3 investigation procedure).No deficiency has been determined for the lots.

• Brand Name: I-STAT CG4+ CARTRIDGE
• Type of Device: CG4+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 7850125
• MDR Text Key: 120251196
• Report Number: 2245578-2018-00231
• Device Sequence Number: 1
• Product Code: KHP
• UDI-Device Identifier: 10054749002266
• UDI-Public: 10054749002266
• Combination Product (y/n): N
• PMA/PMN Number: K982071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2019
• Device Catalogue Number: 03P85-50
• Device Lot Number: D18176A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: 09/27/2018
• Supplement Dates FDA Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR