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

Catalog Number 04P75-01

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024, abbott point of care (apoc) was contacted by a customer who reported that i-stat 1 analyzer sn (b)(6) yielded quality check code 43 while running cartridge test.The customer also stated that the keys were not responding.There were no other reports from the customer/user.The analyzer was returned for repair and on (b)(6) 2024, during repair analysis, some of the inter components were found burn and the analyzer would not activate.The repair site presented pictures of the components that were found charred/burnt and melted barcode scanner.Pictures of the batteries used were not provided but requested.Cosmetic damage was also noted on 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.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.

Manufacturer Narrative

Apoc incident #(b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Manufacturer Narrative

Apoc incident: (b)(4) the investigation was completed on 08-may-2024.The customer reported that analyzer s/n (b)(6) generated quality check code (qcc) 43 when testing cartridges.The customer also stated that the keys were not responding.The analyzer was returned for repair and the distributor repair center (drc) reported cosmetic damage and multiple burned components were noted.The drc also reported that qcc 66 was observed during failure analysis.Failure analysis confirmed the complaint of the unresponsive keypad upon receipt (determined to be caused by the melted keypad bezel).Qcc 43 could neither be confirmed via the analyzer memory (failed to transmit) nor reproduced (unable to perform testing).Visual inspection observed multiple burned components which prevented further failure analysis especially on the main pcb.Per the incident summary, the customer reported placing the analyzer on a baby warmer in an attempt to resolve qcc 43.Additionally, the customer was using 9 volt duracell alkaline batteries instead of 9-volt lithium batteries (apoc list number: 06f21-26) that are recommended per art: 714364-00y, of the i-stat system manual [ref.2] the 9-volt lithium batteries have a safety feature that provides protection preventing the i-stat 1 analyzer from overheating due to component failure within the analyzer circuitry.A rocket ware search spanning three months revealed no similar incidents.No deficiency has been identified.

• Brand Name: I-STAT1 ANALYZER, IMMUNO READY
• Type of Device: 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 ; 400 college road; princeton, nj 08540 ; CA 08540
• MDR Report Key: 18836633
• MDR Text Key: 337018361
• Report Number: 2245578-2024-00050
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00054749000340
• UDI-Public: 00054749000340
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K103195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04P75-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1