MAUDE Adverse Event Report: TOSOH CORPORATION G7

Model Number G7

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/26/2016

Event Type  malfunction  

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).Fse was dispatched and on (b)(6) 2016 found obstruction of x1 axis.Had to remove the back of sample loader to find and remove the obstruction in path.Ran qc (quality control) and some patients with no errors.The most probable cause of the reported event was that x1 axis had an obstruction in path.

Event Description

On (b)(6) 2016 the customer reported x 1 axis error with their hlc723g7 analyzer.Ts had account reboot analyzer and repeat samples.Rack moves as normal but analyzer alarms.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: 7382300
• MDR Text Key: 104148708
• Report Number: 8031673-2018-03702
• 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: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 03/29/2018
• Distributor Facility Aware Date: 09/26/2016
• Device Age: 10 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/29/2018
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2008
• 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