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

Model Number G8

Device Problem High Readings (2459)

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

Event Date 12/31/2018

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: a 13-month complaint history review and service history review for similar complaints was performed for aia-pack hba1c quality control set, lot number 7081, from 30-nov-2017 through aware date (b)(4) 2018.There were five (5) similar complaints identified during the searched period, which includes this event.A 13-month complaint history review and service history review for similar complaints was performed for aia-pack hba1c calibrator set, lot number zs7002, from 30-nov-2017 through aware date (b)(4) 2018.There were no other similar complaints identified during the searched period.The hemoglobin a1c st aia-pack hba1c analyte application manual states the following: evaluation of results 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 could not be determined.The issue was resolved after running a new aia-pack hba1c quality control set.(b)(4).

Event Description

A customer reported out of range high level 2 quality control (qc), lot number 7081, on hba1c with the g8 analyzer.The customer reported that quality controls were fresh and calibrated with calibrator set, lot number zs7002.The technical support specialist (tss) advised the customer replacing the elution buffers, because it was confirmed that the bags were not dated.The customer was instructed to prime, re-calibrate, and repeat qc.The customer reported that after replacing reagents qc was within acceptable range.The customer called the following day stating that level 2 qc was out of range, but did not provide any specific data.The tss sent new qc and column in efforts to resolve the issue.The customer reported that after re-calibrating and running new qc, lot number 7081, the issue was resolved.All qc results were within acceptable range.No further action was required.The reported event resulted in delayed reporting of patient 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
• 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 (MANUFACTURER); 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: 8245768
• MDR Text Key: 134464467
• Report Number: 8031673-2018-05445
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971103
• 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: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• 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: 01/14/2019
• Distributor Facility Aware Date: 12/31/2018
• Device Age: 2 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/14/2019
• Date Manufacturer Received: 12/31/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2016
• 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