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 06/26/2021

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) 2021, abbott point of care (apoc) was contacted by a customer who reported observing smoke coming analyzer sn (b)(4).There was no additional information at the time of this report.There were no injuries reported.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.In this case the customer stated a green (non-fused) battery carrier is in the i-stat1 analyzer.The customer was advised of the use error in using discontinued product.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 (b)(6)-2021.The customer reported smoke was emitted from the battery compartment of analyzer s/n(b)(6).Failure analysis determined that the cause of the complaint was the failure of a 100 f tantalum capacitor (apoc p/n: 013827-01 01) c26 on the main board of the analyzer, between the primary battery and ground.The capacitor had failed such that it created a short circuit between the battery and ground; current flowing through the shorted capacitor caused heat damage, which gave the capacitor a burned appearance.The battery carrier and 9-volt lithium batteries in use at the time of the incident were not returned with the analyzer.The failures of the tantalum capacitors are a characteristic of the part and should be attributed to the manufacturer's reliability of this type of capacitor.According to the trending data for (b)(6) 2021, the number of capacitor failures in the model 300 analyzer that are allowable based on the component's reliability calculations is 202 for the past year (ending in (b)(6) 2021), and the total number of actual failures is 68, the current incident included.Therefore, no preventive/corrective action is required as the threshold has not been tripped and no product deficiency was found associated with the smoke emitted by the analyzer.Rather, this was a malfunction, which was attributed to the failure of the tantalum capacitor in the c26 location.

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: 12136774
• MDR Text Key: 261226368
• Report Number: 2245578-2021-00058
• 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: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• 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: 08/03/2021
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1