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 12/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) visited the customer to address the reported event.During servicing, fse verified both errors by viewing the printouts and error log.Fse found the column peek tubing was loose which resulted in the a1a not detected error.Fse cleaned and lubricated the large syringe lead screw.Fse validated instrument by successfully completing a precision run and quality control run; all results completed without errors and within acceptable ranges.No further action required by field service.The g8 instrument is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4).There were four (4) 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: 706 syringe-l error: explanation: operation error in syringe-l.Countermeasure: inspect x1-axis.Inspect syringe-l.Execute smp.Reset.221 #### not detect (#### is the peak id) is generated when a specific peak (hemoglobin fraction) could not be detected.When this occurs repeatedly with some samples, the elution buffer may have become concentrated, resulting in unidentified peak detection on chromatograms.Never mix the buffers.When the error only occurs with specific samples, a hemoglobin variant may be present.In chapter 3, assay operations states the following: test report interpretation, indicates the name of hemoglobin fraction identified corresponding to each peak for a1a, a1b, f, la1c+, sa1c, a0.P00, p01, p02, etc., are assigned to unidentified peaks and are printed below the chromatogram.The most probable cause of the reported event was due to dirty sy-l lead screw and loose column peek tubing.

Event Description

The customer reported getting a 706 syringe-l and 221 peak not detected error messages on the g8 instrument.The customer removed the cover to observe the syringe movement and noticed that it was making an unusual sound when it moves.The customer primed buffers and wash, and syringe continued making unusual sound.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 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, japan 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6509368123
• MDR Report Key: 8279934
• MDR Text Key: 136147826
• Report Number: 8031673-2018-05439
• 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: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• 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: 01/25/2019
• Distributor Facility Aware Date: 12/28/2018
• Device Age: 3 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/25/2019
• Date Manufacturer Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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