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

Catalog Number 03P75-06

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(4).On (b)(6) 2018 the customer reported that downloader recharger involved also became hot to the touch.Refer to apoc incident # (b)(4).Product: 04p73-04r, description: i-stat 1 d/r drc-300, kit, sn: (b)(4), mfg date: 04/06/2018.Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On (b)(6) 2018, abbott point of care (apoc) was contacted by a customer who reported that i-stat1 sn (b)(4) is displaying code 86 and is hot to the touch.The customer reports that there was no impact or delay to patient care.There were no injuries reported.The analyzer was replaced at no charge and returning for investigation.On (b)(6) 2018 the customer reported that downloader recharger sn (b)(4) also became hot to the touch that was being used during the event.There were no injuries reported on the second call.(b)(4) was replaced at no charge and also 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).The investigation was completed on 02/12/2019.The customer reported that downloader recharger (drc) s/n (b)(4) was hot to touch when an i-stat analyzer was docked on it.The customer also reported that the cables in use were provided by apoc.The cause was determined to be defective components u12, r54, d14, q1 and q2 on the main board of the drc.A deficiency has been identified.A rocketware search spanning six months revealed no similar incidents and no evidence of a trend.No corrective or preventive action is required at this time.Analyzer s/n (b)(4) was reported to be functioning as expected by the customer.

• 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
• MDR Report Key: 8156728
• MDR Text Key: 131410956
• Report Number: 2245578-2018-00314
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00054749002528
• UDI-Public: 00054749002528
• Combination Product (y/n): N
• PMA/PMN Number: K103195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03P75-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1