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

Device Problem Environmental Compatibility Problem (2929)

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

Event Date 05/28/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4) apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on (b)(6) 2022.The conclusion of the investigation is that the fire started in the outside pocket of the cloth bag where three loose 9v batteries were stored alongside conductive material (paperclip/zipper).The conductive material contacted both the positive and negative end of one or more of the 9v batteries causing the material and/or the battery to heat up and ignite.The warning label of the silver ultralife battery states: do not place loose battery in pocket or elsewhere or store with hazardous or combustible materials.May leak, flame or explode if disassembled, shocked, charged, connected together, mixed with used or other batteries, exposed to fire or high temperature.A rocketware search spanning two years found no related incidents.No deficiency has been identified.

Event Description

On (b)(6) 2022, abbott point of care (apoc) was contacted by a customer who reported that an i-stat1 caught fire.The customer reported taking analyzer out of the box and placing it on top of the box and walked away and fire alarms were triggered.The customer also reported that i-stat 1 1 downloader recharger (drc) s/n (b)(4) was sitting in a cloth bag inside of a cardboard box when a fire began.Alinity instrument s/n 805801 and i-stat 1 analyzer s/n (b)(4) were atop the box and were also damaged by the fire.The analyzer was not sitting in the downloader at the time of the event.There was nothing around analyzer flammable when fire started.The customer further stated that there were three loose disposable batteries in a pouch at the time of the event.The product was being returned for investigation.Based on the information available, there were no patient or user related injuries associated with this complaint.

• 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): ABBOTT POINT OF CARE INC.; 400 college road; princeton NJ 08540 3629
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 14803110
• MDR Text Key: 301512210
• Report Number: 2245578-2022-00083
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2022
• Initial Date FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1