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

Model Number G8

Device Problem High Readings (2459)

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

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fse arrived onsite to address the reported event.Upon review of the customer's calibration and qc results, fse noted a slight shift.Fse confirmed the column count to be 2390 injections.Fse replaced the column, recalibrated and ran qc.No further issues were noted.No further action was required by field service.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 18aug2017 through aware date (b)(6) 2018.There were no similar complaints identified during the search period.The g8 operator's manual under chapter 3, assay operations, was reviewed: 3.5 daily check be sure to check the following items before starting an assay (start command).The hemoglobin a1c st aia-pack hba1c package insert states the following: quality control: in order to monitor and evaluate the precision of the analytical performance, it is recommended that aia-pack hba1c control set be assayed daily.The minimum recommendations for the frequency of running control material are: after calibration, controls are run in order to confirm the calibration curve.Controls should be run if certain service procedures are performed (e.G.Temperature adjustment, sampling mechanism changes, maintenance of the wash probe or detector lamp adjustment or change).After daily maintenance, controls should be run in order to verify the overall performance of the tosoh aia system analyzer.If one or more control sample value(s) is out of the acceptable range, it will be necessary to investigate the validity of the calibration curve before reporting patient results.Standard laboratory procedures should be followed in accordance with the regulatory agency under which the laboratory operates.The most probable cause of the reported event was due to failure of the column.

Event Description

The customer reported out of range high level 2 quality control (qc) with lot number 7076 on their g8 analyzer.The customer recalibrated and reran qc, which repeated with high level 2 result.The customer was not able to get level 2 of qc within acceptable range even after recalibrating the g8 analyzer with a new lot of calibrator.The customer requested service in order to further investigate the out of range qc results.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).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 105-8 623; JA 105-8623
• 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,
• MDR Report Key: 7932488
• MDR Text Key: 123394593
• Report Number: 8031673-2018-00913
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• 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: 10/03/2018
• Distributor Facility Aware Date: 09/18/2018
• Device Age: 4 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 10/03/2018
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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