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 12/15/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, abbott point of care was contacted by a customer regarding i-stat crea cartridges that yielded a suspected discrepant creatinine result of 4.0 mg/dl on a patient.There was no patient information available at the time of this report.(b)(6).Test/collection times not provided.There are no injuries associated with this event.Patient medication was requested as it is suspected that patient may be taking hydroxyurea.I-stat results can be higher than normal with the use of hydroxyurea, a substance that is known to interfere with the i-stat creatinine assay.Refer to art: 714183-00 rev aa.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 10-jan-2022.A review of the device history record confirmed the lot passed finished goods release criteria.Retained cartridge testing for the lot met the 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.

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: 13170128
• MDR Text Key: 290962375
• Report Number: 2245578-2022-00002
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 10054749000125
• UDI-Public: 10054749000125
• 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: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2022
• Device Catalogue Number: 03P84-25
• Device Lot Number: A21239A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2021
• 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