MAUDE Adverse Event Report: TOSOH CORPORATION G7

Model Number G7

Device Problem Use of Device Problem (1670)

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

Event Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched on.(b)(4) 2015.The fse arrived at the site for a sample error and by trouble shooting he found that the needle had a slight bend and also the alignment was off and needed to be adjusted.To verify the fse ran 2 racks of patients and qc (quality control) with no sample errors.No further action is required by field service.The g7 analyzer was functioning as intended and errors cleared.The most probable cause of the reported event was the sampling unit, fault or failure of sample unit a bent needle and alignment needed to be adjusted.(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).

Event Description

On (b)(6) 2015 a customer reported rack movement issues, racks not being indexed correctly and sampling between tubes with their g7 analyzer.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: 7389149
• MDR Text Key: 104276083
• Report Number: 8031673-2018-05010
• 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: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• 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: 04/02/2018
• Distributor Facility Aware Date: 09/21/2015
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/02/2018
• Date Manufacturer Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2008
• 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