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

Model Number G8

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint was dispatched to the field service engineer (fse) department for further investigation.The fse verified the reported error by the customer.During the investigation of the instrument the fse found that the switching power supply was causing the power breaker to switch off.The fse replaced switching power supply and initiated warm up.A quality control run was performed by the fse and the results were within specification.The instrument is functioning as intended and was released.No further actions are required by the fse.A complaint history review and service history review for similar complaints was performed for serial number (b)(4) from the (b)(6) 2017 through awareness date on the (b)(6) 2018.There were no similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 3, assay operation, states the following: the 3.2 power on.Turning main power on.The main power switch of the analyzer is located at the back of the left side, just above the ac inlet.The side marked "i" indicates power on, and the side marked "o" indicates power off.The main power switch also acts as a breaker.If the main power switch is turned off immediately after the power is turned on, the analyzer may short-circuit.If this should occur, be careful not to touch any metal parts of the analyzer.Immediately turn the main power off, unplug the power cord from the power socket and contact a service representative.The most probable cause of the reported issue was due to failure of 12 v switching power supply.(b)(4).

Event Description

The customer reported their g8 instrument will not turned on.Customer stated that when the power switch on the side is turned on it switches back off automatically.And if the instrument is unplugged, the power switch can be turned on but as soon as the instrument is plugged in it switches off.The instrument was plugged into a ups but customer has tried plugging it in directly to the wall and the same thing happens.Field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of hemoglobin a1c (hba1c) patient results.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: the switching power supply was returned for investigation.Visual inspection of the returned part has confirmed the failure of the switching power supply.The most probable cause of the reported issue was due to failure of 12 v switching power supply.

• Brand Name: TOSOH HLC-723G8 ANALYZER
• 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: 7564061
• MDR Text Key: 110462368
• Report Number: 8031673-2018-00492
• 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,Followup
• Report Date: 06/20/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2018
• Distributor Facility Aware Date: 05/21/2018
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2018
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/03/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• 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