MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT ALINITY INSTRUMENT

Catalog Number	02R60-01
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2022
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 (b)(6) 2022, abbott point of care (apoc) was contacted by a customer who reported that i-stat analyzer sn (b)(4) was extremely hot before they powered it off the evening before the error code 0500.0001.0001.0003.0001 appeared 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 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 01-jun-2022.The customer reported that i-stat alinity analyzer s/n (b)(6) generated code 0500.0001.0001.0003.0001, and the code was resolved when the instrument was restarted.The customer also reported that the instrument was hot to touch before it was powered off, which occurred the evening before the error code appeared.The conclusion of the investigation is that the complaint is not confirmed.Further investigation on the issue cannot be performed without return of analyzer s/n (b)(6) to apoc-princeton.A rocketware search spanning one year found no related incidents.No deficiency has been identified.Correction: b3 event date changed from (b)(6) 2022.

• Brand Name: I-STAT ALINITY INSTRUMENT
• Common Device Name: I-STAT ALINITY INSTRUMENT
• 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: 13789990
• Report Number: 2245578-2022-00043
• Device Sequence Number: 4023262
• Product Code: CGA
• UDI-Device Identifier: 00054749002597
• UDI-Public: 00054749002597
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 06/07/2022

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: 02R60-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2019
• 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