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

Catalog Number	04P75-03
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On 25-jan-2022, abbott point of care (apoc) was contacted by a customer who reported observing smoke coming from the compartment of i-stat analyzer (b)(4) during operation.The product did not become hot to the touch.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.The analyzer was operating on rechargeable batteries at the time of the event.At this time there is no reason to believe product will become hot to the touch.The product was replaced and returning for investigation.Based on the information available, there were no patient or user related injuries associated with this complaint.
Additional Manufacturer Narrative
Apoc incident:(b)(4).The investigation was completed on 12-jul-2022.The customer reported that smoke was emitted from the battery compartment of analyzer s/n (b)(6) during operation.The customer also reported the analyzer was warm when the smoke was observed and they were using an i-stat rechargeable battery.A subsequent attempt to activate the analyzer using a different battery was unsuccessful.Failure analysis confirmed the complaint of inability to activate the analyzer, and the cause was determined to be the failure of component tv4 on the battery contact pcb.This is also the likely source of the smoke that was reported by the customer, as tv4 was found to be burnt.The rechargeable battery that was in use at the time of the incident was not returned, and therefore cannot be ruled out as a contributing factor.
Event or Problem Description
Na.

• Brand Name: I-STAT1 ANALYZER, IMMUNO READY, WIRELESS
• Common Device Name: 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; singapore 33921 1; SN 339211
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 13415716
• Report Number: 2245578-2022-00019
• Device Sequence Number: 20141814
• Product Code: CGA
• UDI-Device Identifier: 00054749005529
• UDI-Public: 00054749005529
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K001387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 04P75-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown