MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. TOSOH HLC-723G8 ANALYZER G8

Model Number G8

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).Customer reported entire building lost power.Analyzer now requiring system card to boot up.Verified v5.23.Ts sent card with next day delivery.Even though the fse was not dispatched, this incident occurred on friday (b)(4) 2016 and the system card was not sent until saturday 09-apr-2016.The most probable cause of the reported event was due to power failure.

Event Description

On (b)(6) 2016, the customer reported power failure with their hlc-723g8 analyzer.Customer reported entire building lost power.Analyzer now requiring system card to boot up.Verified v5.23.Ts sent card with next day delivery.The customer is unable to run hba1c patient samples.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city OH 43123
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city OH 43123
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7385922
• MDR Text Key: 104159311
• Report Number: 3005529799-2018-03715
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G8
• Device Catalogue Number: 021560
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1