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

Catalog Number 03P84-25

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2021

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 25-jun-2021, abbott point of care was contacted by a customer regarding i-stat crea cartridges that yielded a suspected discrepant creatinine result of 2.9 on an 84 year old female patient presented for a study scan and angiogram.There was no additional patient information available at the time of this report.Return product is available for investigation.Method:i-stat ; result : 2.9; date : (b)(6) 2021; time: 15:00.Lab , 0.9 , (b)(6) 2021 , 23:32.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.

Manufacturer Narrative

Apoc incident: # (b)(4).The investigation was completed on 26-jul-2021.A review of the device history record confirmed the lot passed finished goods release criteria.Retained and returned cartridge testing met the applicable acceptance criteria found in q04.01.003 rev.Ag, appendix 1- product complaint level 2 and level 3 investigation procedure.No deficiency has been identified for crea cartridge lot a21134.

Event Description

Na.

• Brand Name: I-STAT CREA CARTRIDGE
• Type of Device: CREA+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 12084227
• MDR Text Key: 258944622
• Report Number: 2245578-2021-00057
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 10054749000125
• UDI-Public: 10054749000125
• Combination Product (y/n): N
• PMA/PMN Number: K973292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2021
• Device Catalogue Number: 03P84-25
• Device Lot Number: A21134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR