MAUDE Adverse Event Report: ABBOTT POINT OF CARE INC. I-STAT TROPONIN (CTNI) CARTRIDGE; CTNI CARTRIDGE

Catalog Number 03P90-25

Device Problem False Positive Result (1227)

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

Event Date 02/07/2024

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 07-feb-2024, abbott point of care (apoc) was contacted by a customer regarding i-stat troponin cartridges that yielded a false positive discrepant result of 0.16 ng/l on a patient.There was no patient information at the time of this report.Method; date & results.I-stat, 10:09 & 0.16.I-stat, 10:23 & 0.02.I-stat, 10:53 & 0.00.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on the limited information available that suggested that product was not performing within the variability.There is no evidence the pateint suffered an mi.The investigation is underway.Per i-stat system manual: art: 715595-00v.Reportable range: 0.00 - 50.00.Reference range: 0.00 - 0.03 (represents the 0 to 97.5% range of results).Reference range: 0.00 - 0.08 (represents the 0 to 99% range of results).

• Brand Name: I-STAT TROPONIN (CTNI) CARTRIDGE
• Type of Device: CTNI CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE INC.; 400 college road; princeton NJ 08540
• 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
• MDR Report Key: 18696297
• MDR Text Key: 335812561
• Report Number: 2245578-2024-00025
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K031739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03P90-25
• Device Lot Number: B23287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2023
• 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