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

Catalog Number	04P75-01
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, abbott point of care (apoc) was contacted by a customer who reported that i-stat1 analyzer sn (b)(6) was burned, unable to boot.The analyzer was returned to flextronics, singapore for repair.There was no external damage to the analyzer, nor evidence of burn on the exterior.During analysis the capacitor c26 was found burnt.On 17-sep-2023 apoc became aware the customer experienced visual smoke coming from the analyzer.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, using i-stat rechargeable batteries at the time of the event.Therefore, the analyzer is unlikely to become hot to touch, failing safe.The was repaired and returned to the customer.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 20-sep-2023.On 17-sept-2023, regional customer service manger, china emailed tss.Business partner reported that smoke was observed coming from the inside of the analyzer.Analyzer s/n (b)(6) was returned because it would not activate with an i-stat rechargeable battery, and it emitted smoke as later reported on 17-sep-2023.Failure analysis determined that the cause of the complaint was the failure of a 100f tantalum capacitor (apoc p/n: 013827-01 01) c26 on the main board of the analyzer, between the primary battery and ground.The capacitor had failed such that it created a short circuit between the battery and ground; current flowing through the shorted capacitor caused heat damage, which gave the capacitor a burned appearance.There is no reason to suspect that the failed capacitor while using a rechargeable battery is likey to become hot to the touch, nor cause or contribute to a death or serious injury.The product failed safe.

• Brand Name: I-STAT1 ANALYZER, IMMUNO READY
• Common Device Name: I-STAT1 ANALYZER
• Manufacturer (Section D): ABBOTT POINT OF CARE INC.; 400 college road; princeton NJ 08540
• Manufacturer (Section G): FLEXTRONICS MANUFACTURING (SINGAPORE); pte ltd; 1 kallang place; singapore 33921 1; SN 339211
• Manufacturer Contact: linda maczuszenko ; pte ltd; 1 kallang place; singapore, NJ 33921-1 ; SN 339211 ; 6136123525
• MDR Report Key: 17774757
• Report Number: 2245578-2023-00127
• Device Sequence Number: 6114055
• Product Code: CGA
• UDI-Device Identifier: 00054749000340
• UDI-Public: 00054749000340
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/22/2023

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: 04P75-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2013
• 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