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

Catalog Number 03P75-01

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 10/16/2020

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 i-stat analyzer sn (b)(4) was hot to touch.There was no additional information at the time of this report.Apoc has replaced the analyzer at no charge to be returned 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 states that rechargeable batteries were being used at the time of the event.Therefore the analyzer is unlikely to 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

Apoc incident: (b)(4) the investigation was completed on 17-dec-2020.The customer reported that analyzer (b)(6) displayed the "low battery" message while using two disposable 9-volt alkaline batteries, and the batteries were hot to touch when removed from the analyzer.Failure an (b)(6) alysis could not be performed as analyzer (b)(6) has not been returned to abbott point of care.A search was performed using the complaint handling system spanning six months revealed no similar incidents and no evidence of a trend.No deficiency has been identified.

Manufacturer Narrative

Apoc incident: (b)(4).The investigation was completed on (b)(6) 2021.The customer reported that analyzer s/n (b)(6) displayed the "low battery" message while using two disposable 9-volt alkaline batteries, and the batteries were hot to touch when removed from the analyzer.Failure analysis did not reproduce either part of the complaint.A defective battery contacts board was determined to be the likely cause of the "low battery" message.There is insufficient evidence that the defective battery contacts board caused the batteries to become hot to touch at the customer site.For disposable battery use in the i-stat 1 analyzer, the i-stat system manual recommends using lithium batteries.Alkaline batteries are not recommended for use in the i-stat 1 analyzer.A rocketware search spanning six months revealed no similar incidents and no evidence of a trend.No deficiency has been identified.

Event Description

Na.

• 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: 10747995
• MDR Text Key: 213673808
• Report Number: 2245578-2020-00110
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00054749001408
• UDI-Public: 00054749001408
• Combination Product (y/n): N
• PMA/PMN Number: K103195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2021

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 Catalogue Number: 03P75-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 12/17/2020; 02/19/2021
• Supplement Dates FDA Received: 12/23/2020; 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1