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 Problem No Information (3190)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded suspected discrepant pt/inr results on patient.There was no patient information at the time of this report.Return product is available.Method , date , result.I-stat , (b)(6) 2018 ,>6.0 ; i-stat , (b)(6) 2018 , 5.1; acl 5000 , (b)(6) 2018 , 4.8.Collection and test times are unknown there are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on the limited information available that suggests the product was not performing within the variability of the assay.There was no patient or sample handling information available at the time of this review.The investigation is underway.

Event Description

Na.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 07/17/2018.A review of the device history record (dhr) confirmed that the cartridge lot passed release specifications.Retained cartridge testing of pt/inr cartridge lot t18046b met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ac (product complaint level 2 and level 3 investigation procedure).Returned cartridge testing of pt/inr lot t18046b did not meet the acceptance criteria for suppressed results outlined in appendix 1 of q04.01.003 rev.Ac (product complaint level 2 and level 3 investigation procedure.No points were observed outside allowable error (ea).The returned cartridges which were outside of apoc control may have been exposed to environmental conditions that do not meet the package labeling.As indicated in the product receiving table, 28 cartridges were placed in a box which is meant to contain 24 cartridges, it is unclear how many of the returned cartridges are from the box number provided.There is no indication of a lot or sectional issue from retain testing and finished goods testing.This is consistent with q04.01.003 rev.Ac (product complaint level 2 and level 3 investigation), which states that a deficiency cannot be determined solely on return test results.In addition, a search in rocketware on 16-jul-18 indicated that 5,904 cartridges from pt/inr cartridge lot t18046b have been distributed, there are no other complaints for this lot.

• 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: 7573239
• MDR Text Key: 110594160
• Report Number: 2245578-2018-00166
• 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: 07/26/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2018
• Device Catalogue Number: 03P89-24
• Device Lot Number: T18046B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1