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

Catalog Number	03P75-58
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/31/2019
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) 2019, abbott point of care (apoc) was contacted by a customer who reported that i-stat1 analyzer sn (b)(4) became hot to touch.The analyzer was put in the downloader without any battery, for two days, since it was received.The customer has not used the analyzer for any testing and there was no impact to patient care.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 no batteries were being used at the time of the event.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident # (b)(4).The investigation was completed on 01/17/2020.The customer reported that analyzer s/n (b)(6) was hot to touch after being docked in a downloader for two days.The customer added that no battery was installed in the analyzer when docked in the downloader.Failure analysis did not reproduce the complaint.Analyzer s/n :(b)(6).Functioned according to specification throughout testing.The out of box failure rate is below the alert level for (b)(6) 2019.A rocketware search spanning six months revealed no similar incidents and no evidence of a trend.No 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
• MDR Report Key: 9283905
• Report Number: 2245578-2019-00262
• Device Sequence Number: 19263473
• Product Code: CGA
• UDI-Device Identifier: 00054749003792
• UDI-Public: 00054749003792
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K103195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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: 03P75-58
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1