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

Model Number G8

Device Problem Device Operational Issue (2914)

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

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: on 27-mar-2018, a field service engineer (fse) was dispatched to the customer's facility to address the reported event.Fse confirmed the intermittent high baselines by comparing the g8 instrument's chromatogram print out to the chromatogram from the reporting software.Per customer, the results are correct.Fse reloaded the software and advised the customer to continue to monitor the instrument.Patient samples were used to validate correct operation of the analyzer; the resulting chromatogram shows all results are within specification.The g8 instrument functioned as intended and meets the performance requirements.No further action required from field service.A (b)(6) complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.There were no similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 7, data management provides instruction for software reload under section 7.1 data management details from pages 183 to 187: the analyzer's system program and assay parameters are backed up by the internal battery.When a system program version has been upgraded or some problem has corrupted the system program, use the following procedure to reload the program and other data from the smart media socket.The most probable cause of the reported event was due to software needed to be reloaded.

Event Description

On (b)(6) 2018, a customer reported getting intermittent high baseline shift on patient samples on the g8 instrument.Customer stated when the samples are repeated, the baselines are back to normal.On 27-mar-2018, 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 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
• 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 (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: 7453287
• MDR Text Key: 106866676
• Report Number: 8031673-2018-00339
• 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: 04/23/2018

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: 04/23/2018
• Distributor Facility Aware Date: 03/26/2018
• Device Age: 5 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/23/2018
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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