MAUDE Adverse Event Report: TOSOH CORPORATION G7

Model Number G7

Device Problems Decrease in Pressure (1490); Increase in Pressure (1491)

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

Event Date 01/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2016, fse conducted follow-up with the customer over the phone to address the reported event.Fse performed troubleshooting with the customer to reseat the peek tubing from the filter and retighten the filter assembly.The device was primed and quality control (qc) and several samples ran without issue.Fse also verified that the chromatograms looked good.No further action was required by field service.The most probable cause of the reported event was due to fault/failure of the peek tubing from the prefilter.

Event Description

On (b)(6) 2016, the customer reported high, then low pressure, followed by "filter clogged popped tubing" with their g7 analyzer.Technical support (ts) advised the customer to replace the filter, reconnect the tubing, and repeat the patient sample.Ts advised the customer to call back if the issue persisted.On (b)(6) 2016, the customer contacted ts to report that she had replaced the filter but noted that the peak tubing was broken and would not stay attached.On (b)(6) 2016, field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• Brand Name: G7
• Type of Device: G7
• 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: 7339618
• MDR Text Key: 102451779
• Report Number: 8031673-2018-02710
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011434
• 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: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G7
• Device Catalogue Number: 019327
• 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: 03/14/2018
• Distributor Facility Aware Date: 01/05/2016
• Device Age: 9 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/14/2018
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2006
• 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