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

Model Number G8

Device Problems Fluid/Blood Leak (1250); Device Issue (2379)

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

Event Date 07/14/2015

Event Type  malfunction  

Manufacturer Narrative

The complaint was dispatched to the field service engineer (fse) department on the (b)(6) 2015 for further investigation.The fse conducted a follow-up with the customer over-the-phone to address the reported event.During the investigation the fse requested the customer to empty the waste bottle.The customer cleaned the spillage and the watse liquid.The customer ran samples with no errors and no leaks on the instrument.Instrument is functioning as intended.The most probable cause for this event is operator error.(b)(4).

Event Description

On the (b)(6) 2015 the customer reported that leaking from the rear side of their g8 instrument.Customer indicated the chromatorgrams and pressure are normal.The technical support group requested the customer to dry up the leak and examine the instrument to see the origin of the leak.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: 7344200
• MDR Text Key: 103149848
• Report Number: 8031673-2018-01286
• 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: 03/15/2018

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2018
• Distributor Facility Aware Date: 07/14/2015
• Device Age: 4 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/15/2018
• Initial Date Manufacturer Received: 07/14/2015
• Initial Date FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1