MAUDE Adverse Event Report: TOSOH CORPORATION G7

Model Number G7

Device Problem Device Maintenance Issue (1379)

Patient Problem No Information (3190)

Event Date 06/10/2015

Event Type  malfunction  

Manufacturer Narrative

Review of service history for this g7 analyzer revealed the last preventive maintenance performed by tosoh fse was january 21, 2013.The fse went to the customer site to perform preventive maintenance (pm).There is no specific information available from the customer in regard to the failed cap survey.Following completion of pm, the fse performed calibration, ran controls and precision testing and all were within acceptable range.The most probable cause of the reported event is related to inadequate laboratory practices.The g7 operator's, service and training manuals were reviewed and found to clearly address operation, maintenance, calibration and quality controls, and troubleshooting pertaining to the g7 system.(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).

Event Description

On (b)(6) 2015 the customer called tosoh technical support to request preventive maintenance for the g7 analyzer by a field service engineer (fse).The customer further reported failing their cap survey.

• 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, ste 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7336739
• MDR Text Key: 102592670
• Report Number: 8031673-2018-02218
• 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: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• 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: 03/13/2018
• Distributor Facility Aware Date: 06/10/2015
• Device Age: 3 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/13/2018
• Date Manufacturer Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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