MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT 6+ CARTRIDGE

Catalog Number	03P80-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Respiratory Distress (2045)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.
Event or Problem Description
On (b)(6) 2017, abbott point of care was contacted by a customer regarding i-stat 6+ cartridges that yielded suspected discrepant potassium (k) result on a (b)(6) year old male patient with breathing difficulties.There was no additional patient information available at the time of this report.Customer states that return product is available for investigation.(b)(6).Collection and test times are unknown.There was no additional patient information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).The investigation was completed on 01/24/2018.Retain and return product was tested and functioning according to specification.
Event or Problem Description
Na.

• Brand Name: I-STAT 6+ CARTRIDGE
• Common Device Name: 6+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 7080588
• Report Number: 2245578-2017-00618
• Device Sequence Number: 13954334
• Product Code: JGS
• UDI-Device Identifier: 10054749000088
• UDI-Public: 10054749000088
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K912387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2018
• Device Catalogue Number: 03P80-25
• Device Lot Number: K17143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 63