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

Model Number G8

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a distributor field service engineer (fse) was dispatched to resolve reported event.Fse verified customer's complaint.Fse cleaned and replaced the column.Fse successfully completed quality control run within acceptable range.No further action required by field service.The g8 instrument is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4).There were no similar complaints found during the searched period.The g8 operator's manual under chapter 1, introduction and applications, states the following: the unopened tskgel g8 variant hsi column should be stored at 4-15°c in a cool location away from direct sunlight.The column is stable until the expiration date printed on the label.Columns are warranted for 2500 injections.The most probable cause of the reported event was due to operator error: customer used an old or used column.

Event Description

A customer reported getting erratic values with the g8 instrument.No further information provided by the distributor; instrument was down and no patient samples were processed.Customer requested service.A distributor field service engineer (fse) was dispatched to address the reported event, which resulted in delay of results for hemoglobin a1c (hba1c).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Event Description

N/a.

Manufacturer Narrative

H.10.Additional manufacturer narrative: tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number e2017013.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.Corrected data: the initial report submitted on 16-jan-2019 to the agency had the incorrect date of 29-nov-2018 under section g.4.The correct date should have been 17-dec-2018.

• 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, japan 10586 23; JA 1058623
• MDR Report Key: 8255285
• MDR Text Key: 134587513
• Report Number: 8031673-2019-00013
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2019,05/13/2019

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 Model Number: G8
• Device Catalogue Number: 021560
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/16/2019
• Distributor Facility Aware Date: 11/29/2018
• Device Age: 8 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/16/2019
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 04/11/2019
• Supplement Dates FDA Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1