MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT PT/INR CARTRIDGE

Catalog Number 03P89-24

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(6).Additional cartridge lot used on (b)(6) 2020: lot# expiry date mfg.Date: t20300d, 24-apr-2021, 26-oct-2020.Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On (b)(6) 2020, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded a suspected discrepant pt/inr result of 6.1 on an (b)(6) year old male patient with drained bag with blood/bursting from recent hospitalization where patient was discharged on (b)(6) 2020.There was no additional patient information available at the time of this report.Return product is available for investigation.Method date collected tested inr pt sample cartridge lot #: i-stat (b)(6) 2020 12:07 12:07 6.1 67.4 fingerstick t20264a, lab (b)(6) 2020 12:42 14:54 3.87 39.6 venous drawn n/a, i-stat (b)(6) 2020 11:29 11:29 5.2 57.3 fingerstick t20300d, lab (b)(6) 2020 11:54 14:00 2.62 27.0 venous drawn n/a.On (b)(6) 2020 the customer called to report a new test on the same patient with another cartridge lot (t20300d) seen as an outpatient.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on limited information available that suggests the product was not performing within the variability of the assay.The investigation is underway.

Manufacturer Narrative

Apoc incident: (b)(4).The investigation was completed on 11-dec-2020.A review of the device history record (dhr) confirmed that the cartridge lot passed release specifications.Retained and returned cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Af (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified.

Event Description

Na.

• Brand Name: I-STAT PT/INR CARTRIDGE
• Type of Device: PT/INR CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 10935554
• MDR Text Key: 241234033
• Report Number: 2245578-2020-00128
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 10054749000170
• UDI-Public: 10054749000170
• Combination Product (y/n): N
• PMA/PMN Number: K020355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2021
• Device Catalogue Number: 03P89-24
• Device Lot Number: T20264A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR