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

Model Number G8

Device Problem Loss of Data (2903)

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

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.Fse arrived at the site to address the reported event.Upon arrival fse reloaded the 5.23 software, powered up analyzer, and performed scheduled periodic maintenance (pm).No further issues were noted.No further action was required by field service.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.There were no similar complaints identified during the search period.The g8 training manual, version 1.8; under chapter1- daily maintenance, states the following: daily maintenance procedure : switch on analyzer.If power is off press power button.The power led on the left side of the screen will illuminate green.Analyzer begins 9 minute warm-up cycle.If the main power has been shut off; turn on the main power switch on the left side of the analyzer.Press the power key on the operation panel.It is not necessary to reload the system card.Check card storage space (optional).Press menu, then card.The card screen shows remaining card storage space at upper left.Verify raw auto save and lst auto save options.These options can be selected in the parameter file on page 3.Press parameter.Use the down arrow key until page 3 is displayed.Enter 1 to turn option on, 0 to turn option off.The most probable cause of the reported event was due to corrupt operating software.

Event Description

It was reported that the customer experienced a power outage after a storm with their g8 analyzer.When the customer attempted to start the device the next morning, they received a message "corrupt, load system card".The customer was unable to locate a system card for the analyzer.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC.; 3600 gatz road; grove city OH 43123
• Manufacturer (Section G): TOSOH BIOSCIENCE, IC.; 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: 7563625
• MDR Text Key: 110099166
• Report Number: 3005529799-2018-00507
• 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: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• 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: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2015
• 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