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

Catalog Number	03P90-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, abbott point of care (apoc) was contacted by a customer regarding i-stat troponin cartridges that yielded a false positive discrepant result of 160 ng/l on a patient.There was no patient information at the time of this report.Method, date, tested, results, sample: i-stat , (b)(6) 2023, 08:00 ,160 ng/l ,heparinized whole blood.Alinity lab, (b)(6) 2023 , 11:30, <5.1 ng/l , heparin plasma.I-stat , (b)(6) 2023 , 12:00, <30 ng/l , heparinized whole blood.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 patient 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).
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 27-nov-2023.A review of the device history records (dhrs) confirmed the cartridge lots met finished goods (fg) release criteria.Retained cartridge testing for lots b23164 and b23197 met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Al (product complaint level 2 and level 3 investigation procedure).Retained cartridge testing for lot b23086 could not be completed as the investigation was opened after the lot expired on 26-oct-2023.No deficiency has been identified for ctni cartridge lot b23086, b23164 or b23197.

• Brand Name: I-STAT TROPONIN (CTNI) CARTRIDGE
• Common Device Name: 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 ; 185 corkstown road; princeton, NJ K2H 8-V4 ; CA K2H 8V4 ; 6136885949
• MDR Report Key: 17993243
• Report Number: 2245578-2023-00146
• Device Sequence Number: 7313782
• Product Code: MMI
• UDI-Device Identifier: 10054749000187
• UDI-Public: 10054749000187
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K031739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03P90-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown