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

Model Number G8

Device Problem Mechanical Problem (1384)

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

Event Date 12/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fse followed up with the customer via telephone to address the reported event.After confirming the reported error, fse instructed the customer to power the instrument off completely, unplug, re-plug, and then perform the buffer change under maintenance.The error subsequently resolved.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 23nov2017 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: 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.140 buffer empty error: the remaining reagent is low.A message will be displayed only if the alarm is set.The operator is instructed to replace the eluent.The most probable cause of the reported event was due to a fault/ failure of the software.

Event Description

The customer reported receiving the "140 buffer empty" error during start up with their g8 analyzer.The customer stated that the hemolysis wash had been changed because it was empty.The customer replaced the buffer per procedure, primed, and rebooted; however, the error reoccurred.Next, technical support (ts) instructed the customer to perform a drain flush, then try to register the wash again.The customer reported receiving the "140 buffer empty" error again, with the gage still at the empty position.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: 8240598
• MDR Text Key: 134334269
• Report Number: 8031673-2018-05428
• 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: 12/23/2018
• Device Age: 4 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/11/2018
• Initial Date Manufacturer Received: 12/23/2018
• Initial Date FDA Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2014
• 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