MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT DOWNLOADER RECHARGER; DOWNLOADER/RECHARGER

Catalog Number 04P73-04

Device Problem Fail-Safe Problem (2936)

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

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2023, abbott point of care (apoc) was contacted by a customer reported that i-stat 1 analyzer generated a code 86 and the rechargeable battery (bod 2014-12) charging inside melted within an hours and became hot to touch when removed.Issue with analyzer occurred while it was being charged in i-stat 1 downloader/recharger-network drc-119488.I-stat was not damaged and is still being used in service without issue.Customer confirmed drc-119488 is not able to charge multiple analyzers without analyzer batteries warming up and eventually getting hot.Customer confirmed that using the same analyzers in another drc-300 did not have the same issue.The product was replaced at no charge and returning for investigation.There were no injuries reported.Customer is using rechargeable batteries and the correct power supply was verified.Per i-stat1 system manual: art: 714368-00k, rev.Date: 02-aug-12: the downloader/recharger can recharge a rechargeable battery in the analyzer.If the analyzer contains a rechargeable battery, the battery begins recharging automatically as soon as the analyzer is placed in the downloader/recharger.The downloader/recharger also has a compartment for recharging a rechargeable battery outside the analyzer.Placing an analyzer in a downloader/recharger will automatically initiate recharging of the rechargeable battery.The indicator light on top of the downloader/recharger will be green (trickle charge), red (fast charge), or blinking red (fast charge pending) when an analyzer with a rechargeable battery is placed in the downloader/recharger.As well, placing a rechargeable battery into the recharging compartment will automatically initiate trickle recharging.The indicator light near the recharging compartment will be green when a rechargeable battery is placed in the compartment.

Manufacturer Narrative

Apoc incident: (b)(4).The investigation was completed on 13-apr-2023.The customer reported that multiple analyzers, with rechargeable batteries installed, were not able to charge batteries when docked in downloader recharger (drc) s/n (b)(6).Additionally, the rechargeable batteries were hot to touch when removed from the analyzers, and one battery was noted to be "melted." the customer noted that these events did not occur when a different drc was used.Failure analysis confirmed the complaint of inability to recharge a battery and the cause was determined to be the failure of component q1.This is also determined to be the likely cause of the rechargeable battery becoming hot to touch.However, without return of the battery that was in use, the battery itself cannot be ruled out as a contributing factor.As the customer-provided photo of the rechargeable battery does not provide conclusive evidence of any deformity to the battery, the report of the battery being "melted" is not confirmed.A deficiency has been identified.A rocketware search spanning three months revealed no similar incidents and no evidence of a trend.No corrective or preventive action is required at this time.

• Brand Name: I-STAT DOWNLOADER RECHARGER
• Type of Device: DOWNLOADER/RECHARGER
• 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 ; pte ltd; 1 kallang place; singapore, NJ 33921-1 ; SN 339211 ; 6136885949
• MDR Report Key: 16183635
• MDR Text Key: 308918759
• Report Number: 2245578-2023-00009
• Device Sequence Number: 1
• Product Code: JQP
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

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
• Device Catalogue Number: 04P73-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1