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

Catalog Number	04P75-01T
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, abbott point of care (apoc) was contacted by a customer who reported that i-stat1 analyzer sn (b)(4) generated a quality check code 86 during operation.The room temperature is constant 24 hours a day, but error 86 occurred.Customer reported that when they removed the rechargeable battery to acclimatize it to room temperature, it was hot.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).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Additional Manufacturer Narrative
Apoc incident: (b)(4).The investigation was completed on (b)(6) 2022.Failure analysis reproduced the voltage drop but did not reproduce either the hot to touch condition or qcc 86.Failure analysis determined that the cause of the voltage drop was a defective pogo pin j12 on the battery contact pcb.No cause for either qcc 86 or the hot to touch condition was found during testing, and the rechargeable battery that was in use at the customer site was not returned with the analyzer.

• 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: 13577942
• Report Number: 2245578-2022-00029
• Device Sequence Number: 11864556
• Product Code: CGA
• UDI-Device Identifier: 00054749000340
• UDI-Public: 00054749000340
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/27/2022

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: 04P75-01T
• 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: 02/04/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2018
• 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