MAUDE Adverse Event Report: TOSOH CORPORATION G7

Model Number G7

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: (b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).Device by manufacturer: on (b)(6) 2016, an fse was dispatched to the customer facility to address the reported event.Fse began to troubleshoot the issue.Fse cleaned out obstruction on injector valve port #3 to correct issue.Fse also cleaned and lubed large syringe worm screw.Customer then ran 20 plus patients with no problems.The customer ran quality control (qc) in which all results were within acceptable range and verified that the analyzer was functioning correctly.The g7 analyzer was functioning as intended and the errors cleared.No further action required by field service.The most probable cause of the reported event was due to a clog in port #3.

Event Description

On (b)(6) 2016, a customer reported a 706 l (large) syringe error with their g7 analyzer.The customer had already replaced the sample needle, performed a sample reset - needle moves smoothly.Customer cleaned the sample drive gear.The g7 sampled one quality control sample then the error returned.The customer is unable to run hba1c patient samples.A 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 (MANUFACTURER); 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: 7403414
• MDR Text Key: 105248883
• Report Number: 8031673-2018-04167
• 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
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• 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: G7: 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: 04/06/2018
• Distributor Facility Aware Date: 08/10/2016
• Device Age: 10 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/06/2018
• Date Manufacturer Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2006
• 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