MAUDE Adverse Event Report: ABBOTT POINT OF CARE MARTEL PRINTER FOR I-STAT1

Catalog Number 06F23-91

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2019

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) 2019, abbott point of care (apoc) was contacted by a customer who reported that martel printer sn (b)(4) was hot touch using martel battery.Customer replaced the battery with a brand new martel battery, printer is still hot to touch.The customer confirmed that the correct cables and battery are being used with the martel printer.There was no additional information at the time of this report.The printer was replaced and returning for investigation.Based on the information available, there were no patient or user related injuries associated with this complaint.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 06/24/2019.The customer reported that martel printer s/n 230510929 was hot to touch when used with the martel battery.The martel printer was still hot to touch, even after installing a brand-new martel battery.Failure analysis could not be performed as martel printer s/n 230510929 has not been received by apoc.A rocketware search spanning six months revealed no similar incidents and no evidence of a trend.No deficiency has been identified.

• Brand Name: MARTEL PRINTER FOR I-STAT1
• Type of Device: MARTEL PRINTER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 8522244
• MDR Text Key: 142498019
• Report Number: 2245578-2019-00104
• Device Sequence Number: 0
• Product Code: CGA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2019
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 06F23-91
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 06/24/2019
• Supplement Dates FDA Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1