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

Catalog Number 04P75-01R

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(6).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On 11-mar-2023, abbott point of care (apoc) was contacted by a customer who reported that i-stat 1 analyzer sn: (b)(6) would not activate with an i-stat 1 rechargeable battery bod: ni.Customer then replaced the rechargeable battery with 9-volt lithium disposable batteries in a red bottom battery carrier, the analyzer still would not activate.Customer then removed the disposable batteries, analyzer then began to emit smoke, customer reports no flames, not hot or warm to the touch.Customer states he placed the analyzer down, no one was injured and no property damage.Customer was using a red dot fused battery carrier with 9 volt lithium batteries at the time of the event and the product failed safe.Analyzer will be replaced at no charge and 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.There are no injuries associated with the events.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 05-jun-2024.The customer reported analyzer s/n (b)(6) would not activate via rechargeable battery or disposable batteries.The customer also reported the analyzer emitted smoke when they removed the disposable batteries.The customer supplied photos of the analyzer, which depicted a stuck cartridge as well as a broken ir window.Failure analysis determined the smoke was caused by the failure of the c126 tantalum capacitor.This was also the cause of inability to activate the analyzer.Additionally, the complaints of a stuck cartridge and the missing ir window were also confirmed.The cause of the missing ir window was due to a drop, which also caused the out-of-position battery contact pcb.This in turn caused a short circuit between the battery and gnd circuity and may have caused the tantalum capacitor failure.This is likely when the cartridge became stuck.A rocketware search spanning three months revealed no similar incidents.Over the past year, the actual number of incidents caused by reliability-related failures of tantalum capacitors was 39, which is less than the expected 178 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 c126 location.In addition, the component (c126) is not associated with hot to touch and not in the in the vb circuit.The customer was using a fused/rechargeable battery configuration as a power source.There is no reason to believe that the component failures are likely to cause or contribute to death or serious injury.

• Brand Name: I-STAT1 ANALYZER, IMMUNO READY
• Type of Device: I-STAT1 ANALYZER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): FLEXTRONICS MANUFACTURING (SINGAPORE); pte ltd; 1 kallang place; 33921 1; SN 339211
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, nj 08540 ; CA 08540
• MDR Report Key: 18934379
• MDR Text Key: 338316791
• Report Number: 2245578-2024-00059
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00054749003600
• UDI-Public: 00054749003600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2024

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: 04P75-01R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/02/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1