MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT1 ANALYZER, IMMUNO READY, WIRELESS

Catalog Number 04P75-01

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2020

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) 2020, abbott point of care (apoc) was contacted by a customer who reported that analyzer sn (b)(4) that did not activate and also emitted smoke.There was no additional information at the time of this report.The analyzer was replaced at no charge and returning for investigation.Apoc has determined that a component failure within the analyzer circuitry, may lead to the batteries becoming uncomfortably hot to touch in the area of the battery compartment when using a green non-fused battery carrier.However, the customer used disposable alkaline 9v (b)(6) batteries with red carrier.There is no reason to suspect the product would become hot to touch.The product was replaced and returned for investigation.Based on the information available, there were no patient or user related injuries associated with this complaint.

Manufacturer Narrative

(b)(4).The investigation was completed on 24-feb-2021.The customer reported analyzer (b)(6)would not activate and emitted smoke.Failure analysis confirmed the complaint of no activation, and the analyzer likely emanated smoke when the damper surrounding the emt assembly melted.The cause was attributed to the failure of tantalum capacitor c21 on the main pcb.A rocketware search spanning six months revealed no similar incidents.Over the past year, the actual number of incidents caused by reliability-related failures of tantalum capacitors was 85, which is less than the expected 206 obtained by the reliability calculations.Therefore, no corrective/preventive action is required as the threshold has not been tripped and no product deficiency was found.Rather, this was a malfunction, which was attributed to the failure of the tantalum capacitor in the c21 location.

• Brand Name: I-STAT1 ANALYZER, IMMUNO READY, WIRELESS
• Type of Device: I-STAT1 ANALYZER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 11064404
• MDR Text Key: 238828508
• Report Number: 2245578-2020-00136
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00054749000340
• UDI-Public: 00054749000340
• Combination Product (y/n): N
• PMA/PMN Number: K001387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04P75-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1