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

Model Number G8

Device Problems Computer Software Problem (1112); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).Device evaluation by manufacturer: on (b)(6) 2018, a field service engineer (fse) contacted the customer over the phone to address the reported event.The customer confirmed that they were getting a "insert media card" message which occurred after adjusting the flow rate and powering the analyzer down.A smart media card was ordered and the customer was instructed on how to upload it.The customer verified that the instrument was operating as expected.No further action was required by the fse.A 13-month 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 found during this time frame.The g8 operator's manual under chapter 2, preinstallation, states the following: storage device the analyzer is equipped with an internal smart media socket.It is used to store assay results, update and backup program versions.A maximum of 12,000 sets of assay results can be stored on one card (32 mb) formatted by the analyzer.The last 800 sets of assay results are also automatically saved to the analyzer's internal memory.The g8 variant analysis mode training manual under lesson 6 - troubleshooting, states the following: abnormal chromatograms from patients with hemoglobin variants or unknown peaks not recognizedby the analyzer are occasionally seen during routine testing.These patterns may indicate interferences or problems with the assay.Therefore, it is important to use caution when troubleshooting.Review all chromatograms to determine whether the results are valid.In most cases, results for the sa1c% are reportable.In some cases, the sa1c% may be invalid depending on the hemoglobinopathy present, the flow rate, and the condition of the column and reagent system.Adjusting the flow rate - how and why on the tosoh automated glycohemoglobin analyzer hlc-723g8; variant analysis mode it may be necessary to adjust the flow rate because either unidentifiable peaks appear on all the chromatograms or the average retention time for various peaks has changed significantly.The flow rate is changed by changing the flow factor in the instrument.The flow factor is generally 1.00 ml/min.The flow factor should only be adjusted +/- 0.05 of the default factory setting.The most probable cause of the software error was a possible computer glitch.

Event Description

On (b)(6) 2018, a customer reported getting hemoglobin variant (h-v) peaks on two samples and low retention time of 0.56-0.57 (acceptable range is 0.57 to 0.61 minutes) with the g8 instrument.The customer reported that the column count was 519 (column count should not exceed 2500 injections) and the filter was new.Technical support (tss) assisted the customer with adjusting the flow rate from 1.10 to 1.05.The customer then powered off the analyzer and when it was powered back on, the customer was getting an "insert media card" error message.The instrument would not allow for a reboot.The customer could not locate the smart media card to reload the software.A field service engineer (fse) was dispatched to address the reported event, which could have 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.

• 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: 7486288
• MDR Text Key: 107998810
• Report Number: 8031673-2018-00397
• 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: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• 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: 05/04/2018
• Distributor Facility Aware Date: 04/12/2018
• Device Age: 9 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/04/2018
• Date Manufacturer Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2009
• 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