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

Catalog Number	640-0000
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
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 (b)(6) 2021, abbott point of care (apoc) was contacted by a customer who reported that i-stat analyzer sn (b)(4) became hot to the touch during operation.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.The customer states they are using batteries with 9v extended life (non lithium) batteries.Customer was advised that lithium batteries are the recommended batteries for i-stat.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 shipped to the customer on (b)(6) 2013 with a fused battery carrier.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.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 06-dec-2021.A review of the rocketware incident summary determined that the customer was using non-lithium 9-volt batteries, which caused the analyzer to become hot.Art: 714364-00v, page 2-3, of the i-stat system manual states: "the analyzer requires two 9-volt lithium batteries." the customer confirmed that the analyzer has not become hot to touch after they started using 9-volt lithium batteries and they will continue to use analyzer s/n (b)(6).A rocketware search spanning six months revealed no similar incidents and no evidence of a trend.No deficiency has been identified.

• 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): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; 1 kallang place; K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 12625514
• Report Number: 2245578-2021-00080
• Device Sequence Number: 11618399
• Product Code: CGA
• UDI-Device Identifier: 00054749000340
• UDI-Public: 00054749000340
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/07/2021

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: 640-0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2013
• 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