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

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	12/14/2020
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) 2020, abbott point of care (apoc) was contacted by a customer who reported that there was a noise and smoke came from the battery terminals of i-stat 1 analyzer sn# (b)(4).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 power source is unknown at the time of this report.The product was replaced and returned for investigation.Based on the information available, there were no patient or user related injuries associated with this complaint.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Apoc incident: (b)(4).The investigation was completed on (b)(6) 2021.The customer reported that analyzer s/n (b)(6) made a "bang" and smoke emanated from the battery compartment.There is insufficient evidence to determine the cause of the complaint as the analyzer has not been returned to flex.A rocketware search spanning six months revealed no similar incidents and no evidence of a trend.No deficiency has been identified.
Additional Manufacturer Narrative
Apoc incident: (b)(4).The investigation was completed on (b)(6) 2021.The customer reported that analyzer s/n (b)(6) emitted a "bang" sound and smoke emanated from the battery compartment.Failure analysis did not reproduce either part of the complaint and the analyzer functioned according to specification throughout testing.The batteries that were in use at the time of the incident were not returned, and therefore they cannot be ruled out as a contributing factor.A rocketware search spanning one year revealed one similar incident and no evidence of a trend.No deficiency has been identified.
Event or Problem Description
Na.

• 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
• MDR Report Key: 11064402
• Report Number: 2245578-2020-00135
• Device Sequence Number: 2560300
• Product Code: CGA
• UDI-Device Identifier: 00054749000340
• UDI-Public: 00054749000340
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 10/13/2021

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: 08/25/2021
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 03/01/2021; 10/11/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 03/02/2021; 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1