MAUDE Adverse Event Report: TOSOH CORPORATION G8

Model Number G8

Device Problem Output Problem (3005)

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

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.Fse arrived at the site to address the reported event.Fse was unable to confirm or reproduce any errors.Fse removed the column, flushed the system with 15% bleach solution & di water, primed the system, and performed precision and quality control (qc) protocol, all results were within acceptable ranges.Of, note, fse performed pm during the same visit.No further issues were noted.No further action was required by field service.A 13-month complaint service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2018 through aware date (b)(6) 2020.There were no similar complaints identified during the review period.The g8 operator's manual under chapter 5- maintenance states the following: 5.1 daily care: use a cloth dampened with a neutral cleaner to wipe stains from the analyzer's plastic components on the front side (needle cover, etc.).Do not use organic solvents such as ethanol to clean the plastic components.Use a cloth dampened with a neutral cleaner to wipe blots and stains on metallic components as well.If contamination is severe, wipe using a cloth soaked in ethanol.Water remaining on metallic surfaces will cause rust.Lightly wipe away blots and stains on the sample loader belt, display, and key sheet with a cloth soaked in ethanol.The most probable cause of the reported event was due to the instrument requiring maintenance.

Event Description

The customer reported receiving high bias on the college of american pathologists (cap) survey for their g8 analyzer.The customer stated that they failed one hemoglobin a1c (hba1c) sample in the survey, gh-10 10.2; which had a range of 8.9-10.1.All the other samples were at the top of the range.A field service engineer (fse) was dispatched to address the reported event.There was no indication of any patient intervention or adverse health consequences due to the reported event.

• Brand Name: G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9706392
• MDR Text Key: 217719859
• Report Number: 8031673-2020-00020
• 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: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• 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
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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