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

Model Number G8

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: 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)(62) 2018.There were no other similar complaints identified during the searched period, which includes this event.The g8 variant analysis mode 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.708 x1-axis error explanation: operation error in x1-axis countermeasure: inspect x1-axis.Execute sl.Rotate.Chapter 5, maintenance procedures, under section 5.10 provides step-by-step instructions on the sampling needle assembly replacement.The most probable cause of the reported 708 x1-axis error message was due to a bent sampling needle assembly.Additional manufacturer narrative: (b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).

Event Description

A customer reported getting 708 x1-axis error message with a bent sampling needle assembly on the g8 instrument.The technical support specialist (tss) instructed the customer to rotate the sample loader and clean it with an air can.The customer did not have a replacement sampling needle assembly.The tss sent a replacement sampling needle assembly, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).The following day, the customer replaced the bent sampling needle assembly and ran whole blood primers and quality controls (qc) without any further issues.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 105-8 623; JA 105-8623
• 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: 7555660
• MDR Text Key: 110386088
• Report Number: 8031673-2018-00449
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• 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: 05/30/2018
• Distributor Facility Aware Date: 05/02/2018
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2018
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2012
• 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