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

Model Number G8

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

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

Event Date 09/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: field service engineer(fse) was at customer's site to resolve reported event.Fse was informed by customer that qc is out of lab established range.Fse completed preventive maintenance on the analyzer.Customer corrected lab established ranges.No further action required by field service.The g8 analyzer is performing as intended.A complaint history review and service history review for similar complaints was performed for serial number (b)(4).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.Qc materials should be used in accordance with local, state, federal and accredited organizations.Expected reference values: each laboratory should determine a reference interval that corresponds to the characteristics of the population being tested.The most probable cause of the reported issue due to operator error: inaccurate lab established qc ranges.

Event Description

The customer reported mas diabetes control (dbcl) lot number 1809 is trending high in comparison to their quality control (qc) range on their g8 analyzer.The customer did not know where their ranges were obtained: l1 6.3 [customer range 5.7-6.1].L2 9.7 [customer range 8.9-9.7].The lablink peer range was confirmed to be with 2 standard deviation and correct qc ranges: l1 [5.84-6.46].L2 [9.31-10.01].The customer recalibrated and reran qc with result l1 = 6.2 and 6.1; l2 = 9.8 and 9.8, respectively.The customer will be adjusting their qc ranges to align with the lablink peer ranges.The customer will not run the g8 instrument until preventive maintenance is completed, which was coming due.Field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of hemoglobin a1c (hba1c) patient results.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient 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, 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 ; 6509368123
• MDR Report Key: 7920911
• MDR Text Key: 125117666
• Report Number: 8031673-2018-00905
• 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: 09/28/2018

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?: No
• 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: 09/28/2018
• Distributor Facility Aware Date: 09/14/2018
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/28/2018
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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