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 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fse followed up with the customer via telephone to address the reported event.Visual inspection of the waste line revealed whole blood in the mix well which occurred when the patient sample was not being diluted with hemolysis wash.Next, fse instructed the customer to check the sample height detector switches, which detect when the sample cup or is in the rack as it advances through the sampling position.Fse advised the customer that the sampling height detector switches needed to be in the correct position in order for the hemolysis wash to be added to the sample.The customer repositioned the sample detector height switch and was subsequently able to run diluted samples without issue.Fse followed up again with the customer the next day to confirm that the issue had not returned.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 24jun2017 through aware date (b)(6) 2018.There were no similar complaints identified during the search period.The g8 operator's manual under chapter 6- troubleshooting, states the following: 6.3 error messages when consulting with technical support about a problem, please note the error message and error number.In addition, if you follow the suggested solutions in this section and are still unable to resolve the error, or if you encounter an error message that is not noted, contact technical support.General error messages with these errors, the assay stops and the analyzer immediately enters stand-by state.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.The most probable cause of the reported event was due to incorrect positioning of the sample height detector switches.

Event Description

It was reported that the customer received five samples with low total areas and no peaks with their g8 analyzer.Inspection of the device revealed that the container was not full and the fluid was darker than normal, and red in color.The customer also observed that the well where the sample washes, was backed up.The column count was reported to be 3000 injections.The customer stated that they did not have a replacement column on site.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 was 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 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: 7885380
• MDR Text Key: 120739929
• Report Number: 8031673-2018-00874
• 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: 09/14/2018

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: 09/14/2018
• Distributor Facility Aware Date: 07/24/2018
• Device Age: 3 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/14/2018
• Initial Date Manufacturer Received: 07/24/2018
• Initial Date FDA Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2015
• 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