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

Catalog Number	04P75-38
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
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 (b)(6) 2022, abbott point of care (apoc) was contacted by a customer who reported that i-stat1 analyzer sn (b)(4) had a note on it which said "please leave this in docking station to charge.".Customer states that it was not charging and they went to pick it up they realized it was hot to the touch and had a burning smell.The analyzer and rechargeable battery were 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.However, the customer states that disposable lithium batteries in a red carrier were being used at the time of the event.Therefore the analyzer is unlikely to become hot to touch.The product was replaced and is being returned 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 15-aug-2022.The cause of the entire issue was determined to be the stuck pogo pin j5 (therm1).The signal j5 (therm1) did not sense the high temperature when the battery was overcharged.As such, it resulted in the fast charge not being terminated when it reached the maximum cut-off temperature.This led to the hot to touch condition reported by the customer, the rechargeable battery being deformed, the burned component d14 (the likely source of the burnt smell reported by the customer) and failure of the component q1 in the drc.The stuck pogo pins were also the cause of the inability to recharge the battery that was reported by the customer.Analyzer s/n (b)(6) functioned according to specification during failure analysis and did not become hot to the touch.A deficiency has been identified.

• Brand Name: I-STAT1 ANALYZER, IMMUNO READY
• 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: 14521684
• Report Number: 2245578-2022-00080
• Device Sequence Number: 6428875
• Product Code: CGA
• UDI-Device Identifier: 00054749003778
• UDI-Public: 00054749003778
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/16/2022

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: 04P75-38
• 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: 05/24/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2016
• 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