MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8

Model Number G8

Device Problems Loss of Power (1475); Failure to Power Up (1476); Device Operates Differently Than Expected (2913)

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

Event Date 08/08/2015

Event Type  malfunction  

Manufacturer Narrative

The complaint was dispatched to the field service engineer (fse) department on the (b)(6) 2015 for further investigation.During the investigation the fse turned the system on but could not find the as program.The fse reloaded the 5.20 software and the system started up normally.The system was tested with several shut off and start up tries, no errors or issues were noted.Fse ran quality controls as a test of functionality and results were within range.Instrument is functioning as intended and was released.No further action is required by the fse.The most probable cause of the reported event was due to power outage causing the software failure.(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).This report is being submitted due to a retrospective review conducted under (b)(4).

Event Description

On the (b)(6) 2015 the customer reported that their g8 instrument is not working.The customer could not boot the instrument in the morning.The technical support group (tsg) had the customer power down then power up, but the customer was unable to access the instrument software.The customer does not have a software disk to reloaded it on the instrument.Field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hba1c.There is 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 CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7372476
• MDR Text Key: 103555968
• Report Number: 8031673-2018-03917
• 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: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• 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?: Yes
• Date Report Sent to FDA: 03/26/2018
• Distributor Facility Aware Date: 08/08/2015
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2018
• Date Manufacturer Received: 08/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2008
• 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