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

Model Number G8

Device Problem Calibration Problem (2890)

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

Event Date 12/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) visited the customer to address the reported event.Fse confirmed that the calibration was not passing due to air in the system.Fse performed several drain flushes and then ran quality controls with acceptable ranges.There were no p00 peaks found.The instrument was operating as expected.There was no further action required by fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 16-nov-2017 through aware date (b)(4) 2018.There were no similar tickets related to the reported event during the searched period.The g8 operator's manual under chapter 1, introductions 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.Controls should be diluted with hsi hemolysis & wash the most probable cause of the reported event was due to air in the system.

Event Description

A customer reported that they were getting a calibration error with the g8 instrument.The customer stated that the instrument was not giving "proper results" and the printouts had all zeros.Technical support (ts) requested that the customer send printouts for review.Upon follow up, the customer stated that they tried another calibration and it failed after the third repeat of calibration 1.The customer performed a sampler reset.Additionally, when ts instructed the customer to review the error log, they stated that they did not see any error messages since 9 days prior.The instrument was down.A field service engineer (fse) was dispatched to address the reported event, which could have resulted in delay of results for hemoglobin a1c (hba1c).There is 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 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: 8211087
• MDR Text Key: 133378044
• Report Number: 8031673-2018-05399
• 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: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• 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: 01/02/2019
• Distributor Facility Aware Date: 12/16/2018
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2019
• Date Manufacturer Received: 12/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• 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