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 12/14/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, abbott point of care (apoc) was contacted by a customer who reported electronic burning, possibly burnt lithium smell on their i-stat 1 analyzer sn (b)(6).Customer states the analyzer got very hot and had burnt golden contact pads on back side of it where it would dock onto the downloader.Customer states that energizer lithium batteries were used.Customer threw out the box of energizer lithium batteries.A new lot was acquired and run with no issues on other analyzers.Customer states they are using red fused battery carriers and asked if leaving them docked on the downloader overnight may have caused the over-heating.Apoc technical support advised that rechargeable batteries are recommended for the downloader recharger.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).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Manufacturer Narrative

Apoc incident: (b)(4) the investigation was completed on (b)(6) 2024.The customer mentioned that a burning smell was emanating from the analyzer, and the analyzer was hot to touch and the gold recharge contact pins on the back of the analyzer looked burnt.The conclusion of the investigation is that the customer's complaints were confirmed.Although the burnt smell and the hot to touch condition observed by the customer were not reproduced, it was determined that burnt tantalum capacitor c4 on the main board of analyzer s/n 311035 contributed to the burning smell and the hot to touch condition reported by the customer.The capacitor had failed such that it created a short circuit between the battery and ground (gnd); current flowing through the shorted capacitor caused heat damage, which gave the capacitor a burned appearance.Discoloration of the charging pins was confirmed via visual inspection of the analyzer upon receipt, but not in the burnt condition as reported by the customer.It was determined that the discolored recharge pins condition was due to wear and tear usage over the years at the customer's facility.A rocketware search spanning three months revealed no incidents similar to an overheated/hot-to-touch analyzer and no evidence of a trend.Over the past year, the actual number of incidents caused by reliability-related failures of tantalum capacitors was 40, which is less than the expected 181 obtained by the reliability calculations.Therefore, no corrective or 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 c4 location.

• 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 ; pte ltd; 1 kallang place; singapore 33921-1 ; SN 339211
• MDR Report Key: 18354821
• MDR Text Key: 330874763
• Report Number: 2245578-2023-00176
• Device Sequence Number: 1
• Product Code: CGA
• 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,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1