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

Catalog Number	04P75-30
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
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 (b)(4) became hot to touch.The batteries were replaced and the customer noticed the analyzer gave off a spark and started to smoke.There was no additional information at the time of this report.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.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 03-jun-2022.The customer reported that analyzer s/n 308787 was hot to touch.The customer also mentioned that the analyzer sparkled and smoke emanated from the analyzer upon replacement of the batteries.Failure analysis determined the cause of both issues to be a burnt tantalum capacitor found at location c13 on the analyzer main board.

• 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: 14112733
• Report Number: 2245578-2022-00066
• Device Sequence Number: 2121627
• Product Code: CGA
• UDI-Device Identifier: 00054749003693
• UDI-Public: 00054749003693
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 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: 04P75-30
• 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: 04/04/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2005
• 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