MAUDE Adverse Event Report: TOSOH CORPORATION G7

Model Number G7

Device Problem Imprecision (1307)

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

Event Date 06/08/2015

Event Type  malfunction  

Manufacturer Narrative

The complaint was dispatched to the field service engineer (fse) department on the (b)(6) 2015 for further investigation.The fse conducted follow-up with the customer over-the-phone to address the reported event.During the investigation the fse discovered that the reported issue started when the customer replaced buffer #3 on the instrument.The fse advised the customer to replace the buffer #3 on the instrument.Also, the fse asked the customer to run quality control and a patient ten times to verify analyzer is working properly.No error were noted and instrument is functioning as intended.The most probable root cause of this event is operator error during replacement of the buffer #3 bottle.(b)(4).

Event Description

On the (b)(6) 2015 the customer reported that they are having fluctuating and very high hba1c values.The technical support group reviewed the chromatogram and indicated that the customer chromatogram is displaying very large expanded peaks, sa1c of 35.5% next to normal peak.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; 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: 7351942
• MDR Text Key: 103192279
• Report Number: 8031673-2018-01294
• 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: 03/19/2018

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: 03/19/2018
• Distributor Facility Aware Date: 06/08/2015
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/19/2018
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1