MAUDE Adverse Event Report: TOSOH CORPORATION 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 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

Fse arrived at the site to address the reported event.Fse was unable to reproduce the failure of these samples, however, by running a replicate of each fse observed that all the samples of the cap survey were on the edge of the upper limit and that qc results were within acceptable range and close to median for lot 7090.Further inspection of the device revealed that the small syringe was crusted and dirty at the base and that it was bubbling and leaking every time the syringe would move.Fse replaced the small syringe to resolve the issue.Fse was subsequently able to validate the instrument using calibration lot #zs800 by running calibration; qc, cap samples, and patient samples.No further issues were noted.No further action was required by field service.A 13-month complaint service history review for similar complaints was performed for serial number (b)(4) from 05oct2018 through aware date 05nov2019.There were no similar complaints identified during the review period.The st hba1c aia-pack package insert states the following: quality control: in order to monitor and evaluate the precision of the analytical performance, it is recommended that commercially available control samples be assayed daily.The minimum recommendations for the frequency of running internal control material are: after calibration, three levels of controls are run in order to accept the calibration curve.The three levels of controls are also repeated after calibration when 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, at least two levels of the control should be run in order to verify the overall performance of the tosoh aia system analyzers.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 and the assay results before reporting patient values.Standard laboratory procedures should be followed in accordance with the regulatory agency under which the laboratory operates.Limitations of the procedure for diagnostic purposes, the results obtained from this assay should be used in conjunction with other data (e.G., symptoms, results of other tests, clinical impressions, therapy, etc.).The most probable cause of the reported event was due to a worn, leaking small syringe.

Event Description

The customer reported receiving a failed college of american pathologists (cap) survey using tosoh quality control (qc) material, lot# 7076, on their g8 analyzer.The cap survey hemoglobin a1c (hba1c) samples and qc results were reported to be outside of the acceptable range by 0.1%.The customer stated they noticed high bias since the last periodic maintenance (pm) had been performed.The column count was noted to be 2186 injections and sa1crt was 0.60 ml/ min.The reported high bias occurred with multiple columns and calibrations.The customer stated they were using calibration lot # zs-8001.Technical support (ts) instructed the customer to recalibrate with calibration lot # zs-8002, run qc and call back with the results.The customer called back and reported that they installed a new column and recalibrated with the new calibration lot.Both of the qc results were in range per the target ranges, but the upward shift remained.The customer requested service.A field service engineer (fse) was dispatched to address the reported event.There was no indication of any patient intervention or adverse health consequences due to the reported event.

• Brand Name: G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9724183
• MDR Text Key: 205687293
• Report Number: 8031673-2019-00559
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• 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
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• 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