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

Catalog Number	04P75-32
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 04-dec-2023, abbott point of care (apoc) was contacted by a customer who reported that i-stat 1 analyzer (sn (b)(6)) was swollen and burst inside the battery compartment.Business partner replaced the battery and battery carrier but analyzer is not activating.The analyzer 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.There was limited information and battery carrier information was not provided at the time of this report.There are no details surrounding the event, condition of the analyzer in use, nor if the product was being used as intended.There are no injuries associated with the events.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.
Additional Manufacturer Narrative
Apoc incident (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Apoc incident: (b)(4).The investigation was completed on 28-feb-2023.The customer reported that the battery of i-stat 1 analyzer s/n (b)(6) was swollen and had burst inside the battery compartment.The customer also reported the analyzer would not activate after they replaced the battery and the battery carrier.Failure analysis confirmed the complaint of no activation and the cause was determined to be corrupted jam2156a/clew a47 software.During failure analysis, there were no signs of burnt components or short-circuit noted, and no indication that a battery had burst within the battery compartment.As the complaint battery has not been returned for investigation.A rocketware search spanning three months revealed no incidents similar to a reported swollen/burst battery.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
• Manufacturer (Section G): FLEXTRONICS MANUFACTURING (SINGAPORE); pte ltd; 1 kallang place; 33921 1; SN 339211
• Manufacturer Contact: linda maczuszenko ; 185 corkstown road; ottawa, ontario K2H 8-V4 ; CA K2H 8V4
• MDR Report Key: 18266117
• Report Number: 2245578-2023-00174
• Device Sequence Number: 7757019
• Product Code: CGA
• UDI-Device Identifier: 00054749003716
• UDI-Public: 00054749003716
• Combination Product (Y/N): N
• Initial Reporter Country: NP
• PMA/510(K) Number: K103195
• 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): 03/05/2024

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: 04P75-32
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2007
• 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