MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8

Model Number G8

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a 13-month complaint history review and service history review for similar complaints was performed on serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.There were no similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 1, introduction and applications, states the following: quality control in order to monitor and evaluate the accuracy and precision of the analytical performance, controls should be assayed daily and after column replacement.Tosoh suggests running at least two levels of quality control material.The mean of one should be in the non-diabetic range (4-7% hba1c) with the second in the range of 9-12% hba1c.If the value of one or more control specimens is out of the acceptable range, recalibrate the system and rerun the controls before testing patient samples.The most probable cause of the reported event could not be duplicated.The issue resolved after the customer received a new set of properly-labeled samples from american proficiency institute (api).

Event Description

A customer reported that they failed the third high performance liquid chromatography (hplc) event of the american proficiency institute (api) survey samples on the g8 instrument.The customer repeated the samples and got a similar result.The results of the survey were: gly-14: 9.1%, repeat 12.0%, gly-15: 11.8%, repeat 8.9%.The customer used new samples received from api and was able to pass the survey.The customer was told by api that there had been a known mislabeling issue.There is no indication of any patient intervention or adverse health consequences due to discrepant api survey results.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8
• 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: 7988243
• MDR Text Key: 126359629
• Report Number: 8031673-2018-00969
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2018

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: G8
• Device Catalogue Number: 021560
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2018
• Distributor Facility Aware Date: 10/09/2018
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 10/20/2018
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 10/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2011
• 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