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

Catalog Number 03P75-30

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 05/14/2020

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 there was smoke coming from the battery compartment of i-stat 1 analyzer sn# (b)(4), and there was also a burning smell.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 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).Correction (d4) catalog#: change from 03p75-01 to 03p75-30.Udi#: change to (b)(4).The investigation was completed on 07/20/2020.The customer reported analyzer s/n (b)(6) would neither activate nor communicate with the downloader.When the rechargeable battery was re-seated, smoke and a burning smell emanated from the analyzer.Failure analysis confirmed the complaint and the cause was attributed to the failure of the tantalum capacitors c13 and c26 on the main pcb.A rocketware search spanning six months revealed 15 similar incidents.Over the past year, the actual number of incidents caused by reliability-related failures of tantalum capacitors was 87, which is less than the expected 286 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 capacitors in the c13 and c26 locations.The customer was using rechargeable battery packs as a power source.There is no reason to believe that a capacitor failure while using rechargeable battery packs is likely to cause or contribute to death or serious injury.

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
• MDR Report Key: 10074987
• MDR Text Key: 198926880
• Report Number: 2245578-2020-00057
• 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
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03P75-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1