MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT RECHARGEABLE POWER PACK

Catalog Number 04P75-01

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

On 01-nov-2023, abbott point of care (apoc) was contacted by a customer who reported that the rechargeable battery sometimes gets hot, and code 86 frequently occurs while using i-stat 1 analyzer sn (b)(6).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.However, the customer states that rechargeable batteries were being used at the time of the event.Therefore the analyzer is unlikely to become hot to touch.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 25-jan-2024.Failure analysis could not be performed as analyzer s/n (b)(6), drc s/n (b)(6), and the rechargeable power pack have not been returned to flex.S/n (b)(6) and s/n (b)(6): a rocketware search spanning three months revealed no similar incidents and no evidence of a trend.No deficiency has been identified.Rechargeable power pack: a rocketware search spanning twelve months revealed no similar incidents and no evidence of a trend.No deficiency has been identified.

Event Description

Na.

• Brand Name: I-STAT RECHARGEABLE POWER PACK
• Type of Device: RECHARGEABLE POWER PACK
• 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; princeton, nj K2H 8-V4 ; CA K2H 8V4
• MDR Report Key: 18181157
• MDR Text Key: 328627556
• Report Number: 2245578-2023-00165
• Device Sequence Number: 1
• Product Code: FCO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K001387
• 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,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• 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