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 03/05/2024

Event Type  malfunction  

Event Description

On 05-mar-2024, abbott point of care (apoc) was contacted by a customer regarding i-stat troponin cartridges that yielded a false positive result of 0.18 on a 77 year old male patient with lactic acidosis.There was no additional patient information at the time of this report.Return product is not available for investigation.Method date collected tested results i-stat ni 1623 1633 0.18 ng/ml i-stat ni 1818 1827 0.01 ng/ml 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).

Manufacturer Narrative

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

• 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: 18877164
• MDR Text Key: 337352741
• Report Number: 2245578-2024-00054
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 10054749000187
• UDI-Public: 10054749000187
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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: S23352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/18/2023
• 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
• Patient Age: 77 YR
• Patient Sex: Male