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 12/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fse arrived on site to address the reported event.Fse confirmed the reported event and also noted the samples to have p00 peaks and hb-var detect errors.Inspection of the device revealed that a screw was missing for the large syringe from the mounting bracket to the worm drive.Fse replaced the missing screw, a broken hemolysis wash cap assembly, and the pump.Next, fse cleaned the dilution/waste chute for the sampling needle, and adjusted the flow rate from 1.05 to 1.07 minutes to get a retention time of 0.57 to 0.61 ml/min.The customer was subsequently able to run precision, qc, and patient samples without issue.Patient samples now had total areas between 1800 and 2300.No further issues were noted.No further action was required by field service.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 24nov2017 through aware date (b)(4) 2018.There were no similar complaints identified during the search period.The g8 operator's manual under chapter 6- troubleshooting, states the following: 200 area low error: three successive results below the lower limit of the total area (50) occur.If the error message is present when sufficient volume of sample is set in the rack, the problem may be caused by an empty reagent (hemolysis & wash solution).Check the remaining volume of hemolysis & wash solution and start the assay again.6.4 abnormal chromatograms: chromatograms from patients with hemoglobin variants or unknown peaks not recognized by 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.The most probable cause of the reported event was due to a missing screw for the large syringe, a broken hemolysis/ wash line, and failure of the pump.

Event Description

It was reported that the customer received "200 area low" errors with their g8 analyzer.The total areas were low (<200) on both quality control (qc) and patient samples.The customer attempted to troubleshoot by replacing the column; however, the issue persisted.Technical support (ts) instructed the customer verify that the waste line was flowing and there were no leaks.Next, ts instructed the customer replace the sampling needle but the error persisted.A field service engineer (fse) was dispatched to address the reported event which here resulted in a delay in reporting for hemoglobin a1c (hba1c).There was no indication of any patient intervention or adverse health consequences due to the delay in reporting.

• 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 105-8 623; JA 105-8623
• 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,
• MDR Report Key: 8240596
• MDR Text Key: 134333846
• Report Number: 8031673-2018-05431
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2018

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2018
• Distributor Facility Aware Date: 12/24/2018
• Device Age: 8 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/11/2018
• Initial Date Manufacturer Received: 12/24/2018
• Initial Date FDA Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• 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