MAUDE Adverse Event Report: TOSOH CORPORATION G7

Model Number G7

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 09/08/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015, the tss conducted follow-up with the customer over-the-phone to address the reported event.The tss performed troubleshooting with the customer and found all 5 samples were unacceptably high, and the customer was using an older lot of calibrator when the samples were assayed.The customers quality control was also trending higher.On (b)(6) 2015 the customer recalibrated with the current lot of calibrator and control values matched original values.The customer repeated the cap samples which had been stored in the refrigerator but the chromatography was not acceptable due to p00 peaks.She ran a patient comparison and noticed a difference of 0.8%.On 28-oct-2015 the customer reported that she was calibrating a new lot of reagents, which brought the controls into acceptable range.On 10-nov-2018 the customer reported that they did not order new cap survey samples which they originally had planned to do, but a patient correlation demonstrated lower trends which their pathologist reviewed.Because the differences were not clinically significant, the pathologist determined that no corrective reports were needed.The most probable cause of the reported event was due to a defective waste pump.(b)(4).This report is being submitted due to a retrospective review under capa-(b)(4).

Event Description

On (b)(6) 2015, a customer reported that they failed the cap survey with their g7 analyzer.A technical support specialist (tss) spoke with the customer over the phone 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, japan 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7367363
• MDR Text Key: 103731515
• Report Number: 8031673-2018-01013
• 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: 03/23/2018

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: 03/23/2018
• Distributor Facility Aware Date: 09/08/2015
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/23/2018
• Initial Date Manufacturer Received: 09/08/2015
• Initial Date FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: No
• 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