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

Model Number G8

Device Problem Low Readings (2460)

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

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A field service engineer (fse) was dispatched to the customer's facility to address the reported event.The fse spoke with the customer over the phone.The customer found that the sample needle tubing was pinched.The customer adjusted the tubing.All errors cleared and the g8 instrument is operational.No further action is required by field service.The instrument was installed on (b)(6) 2018.A complaint / service history review for similar complaints was performed for the serial (b)(4) from aware date of (b)(6) 2018, which included data from 27 feb 2018 through (b)(6) 2018.There were no similar complaints identified during the searched period, which includes this event.The g8 operator's manual under chapter 6 troubleshooting is as follows: 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 and wash solution).Check the remaining volume of hemolysis and wash solution and start the assay again.The most probable cause for the reported event was the sample needle tubing was pinched.

Event Description

A customer reported error 200 area low on the g8 instrument.The customer stated that the column was replaced prior to the error occurring.The error appeared at the end of the customer running several sample racks.The customer stated that the chromatogram showed there was a lot of noise and a dropped baseline.The customer is unable to run patient samples on hba1c diabetes assay.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hba1c.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-723GA ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; ste. 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7877416
• MDR Text Key: 121564890
• Report Number: 8031673-2018-00824
• 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

• Date FDA Received: 09/14/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2018
• Distributor Facility Aware Date: 08/16/2018
• Device Age: 1 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/14/2018
• Date Manufacturer Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2017
• 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