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 Negative Result (1225)
Health Effect - Clinical Codes	Stroke/CVA (1770); Encephalopathy (1833); Intracranial Hemorrhage (1891); Facial Paralysis (4585)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On 10-oct-2023, abbott point of care (apoc) was contacted by a customer regarding i-stat troponin cartridges that yielded a false negative discrepant result of 0.00 ng/ml on a 72 year old female patient with stroke-like symptoms, left sided facial droop, arm and leg numbness/weakness.There was no additional patient information at the time of this report.Return product is available for investigation.Method: i-stat; date: (b)(6) 2023; collected: 20:04; tested: 20:04; result: 0.00; sample: venous #1.Method: architect; date: (b)(6) 2023; collected: 20:04; tested: 21:00; result (ng/ml): 0.182; sample: venous #1.Method: architect; date: (b)(6) 2023; collected: 00:13; tested: 01:05; result: (ng/ml): 0.174; sample: venous #2.Method: architect; date: (b)(6) 2023; collected: 08:40; tested: 09:57; result (ng/ml): 0.167; sample: venous #3.Positive cut-off value for i-stat troponin test: 0.08ng/ml.Positive cut-off value for architect: 0.030 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).
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 30-oct-2023.A review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Retained and returned cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Al (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified for ctni cartridge lot b23104.

• 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: 17911854
• Report Number: 2245578-2023-00140
• Device Sequence Number: 6636290
• Product Code: MMI
• UDI-Device Identifier: 10054749000187
• UDI-Public: 10054749000187
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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): 10/31/2023

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 Expiration Date: 11/13/2023
• Device Catalogue Number: 03P90-25
• Device Lot Number: B23104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2023
• 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 Age: 72 YR
• Patient Sex: Female