MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CHEM8+ CARTRIDGE

Catalog Number 09P31-25

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

Patient Problem Head Injury (1879)

Event Date 03/11/2018

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (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 chem8+ cartridges that yielded suspected discrepant results on a (b)(6) year old male patient with head trauma / self- inflicted gunshot wound to the head.There was no additional patient information available at the time of this report.Return product is available.(b)(6).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 information available that suggests the product was not performing within the variability of the assay.The investigation is underway.

Event Description

Na.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 04/12/2018.A review of the device history record confirmed the lot passed finished goods release criteria.Retain and returned cartridge test results met the acceptance criteria found in q04.01.003 rev.Ac, appendix 1- product complaint level 2 and level 3 investigation procedure.No deficiency identified.

• Brand Name: I-STAT CHEM8+ CARTRIDGE
• Type of Device: CHEM8+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 7374741
• MDR Text Key: 103944425
• Report Number: 2245578-2018-00117
• Device Sequence Number: 0
• Product Code: JPI
• Combination Product (y/n): N
• PMA/PMN Number: K053110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2018
• Device Catalogue Number: 09P31-25
• Device Lot Number: H17329H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR