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 01/27/2023

Event Type  malfunction  

Event Description

On 02-feb-2023, abbott point of care was contacted by a customer regarding i-stat crea cartridges that yielded a suspected discrepant creatinine results on a 75 year old female patient.There was no additional patient information available at the time of this report.Return product is available for investigation.Method: i-stat, drawn: 15:05, result: 2.6 mg/dl, sample: wb; i-stat, 15:24, 2.4 mg/dl, wb; roche cobas, 16:03, 1.8 mg/dl, plasma.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The investigation is underway.

Manufacturer Narrative

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

Manufacturer Narrative

Apoc incident: # (b)(4).The investigation was completed on 01-mar-2023.A review of the device history record confirmed the lot passed finished goods release criteria.Retained and returned cartridge testing met the acceptance criteria found in q04.01.003 rev.Ak, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.

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
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 16325907
• MDR Text Key: 309530360
• Report Number: 2245578-2023-00017
• Device Sequence Number: 1
• Product Code: CGL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2023
• Device Catalogue Number: 03P84-25
• Device Lot Number: A22259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female