MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8; G8, PRODUCT CODE: LCP

Model Number G8

Device Problems Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

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

Event Date 10/21/2018

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted due to a retrospective review conducted under capa (b)(4).The field service engineer (fse) was dispatched on (b)(6) 2015.The fse confirmed the problem reported and found blockage in the rotor and seal (injector valve).The fse replaced the rotor and seal and found the large syringe was leaking.Fse replaced the large syringe and ran calibration, quality control (qc) and precision.All results were within specifications.The g8 was working as intended.No further action required by fse.The probable cause of the event was partial occlusion of the stator face.

Event Description

On (b)(6) 2015 a customer reported low total area (ta) with their calibrators when run on their g8 analyzer.The customer made fresh calibrators with the same lot and still got low tas.The customer then under diluted the calibrators by 25%, this allowed the calibrators to run but only with tas of 666 and 603; still low but passable.The customer was unable to run samples and requested service to address the reported event.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay reporting hba1c patient results.There was no indication of any patient intervention or adverse event consequence due to the delay of reporting patient results.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8, PRODUCT CODE: LCP
• 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 (MANUFACTURER); 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: 7303871
• MDR Text Key: 101581676
• Report Number: 8031673-2018-01427
• 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: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• 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: 02/28/2018
• Distributor Facility Aware Date: 10/21/2015
• Device Age: 15 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 02/28/2018
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2000
• 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