MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER 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 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a 13 month complaint history review and service history review for similar complaints was performed on serial number (b)(4) from (b)(6) 2019 through aware date (b)(6) 2019.There were no similar complaints identified during the searched period.The g8 operator's manual under chapter 1- introduction & applications state the following: storage and stability: the unopened tskgel g8 variant hsi column should be stored at 4-15°c in a cool location away from direct sunlight.The column is stable until the expiration date printed on the label.Columns are warranted for 2500 injections.The most probable cause of the reported event was the column was being used over the warranty of 2500 injections.

Event Description

The customer reported that they received three hemoglobin a1c (hba1c) patient results that were less than 4.0% on the g8 instrument.The customer reported that when the patient samples were run on a different g8 instrument, the results were reportable.One patient sample obtained an initial hba1c result of 3.4% and when repeated on the second g8 instrument, the hba1c result was 6.4% (refer to associated mfr report #: 8031673-2019-00045/ uf/importer report #: (b)(4) and mfr report #: 8031673-2019-00046 / uf/importer report #: (b)(4) for the other two events).The total areas on both g8 instruments were acceptable and were both using lot n.However, the main g8 the customer was using had a column count of 4008 injections.The customer reported that at the beginning of a run, the hba1c results were acceptable and then the results drop to less than 4.0% without any flags or error messages.The sample needle had been changed and the diluent and wash wells were cleaned.The technical support specialist (tss) suggested that the customer replace the column on the main g8 which had the hba1c results of less than 4.0%.Upon followup, the customer reported that after replacing the column on the main g8 instrument, they performed a correlation between the main g8 instrument and the second g8 instrument and found that the results of both instruments had reportable reports.Quality controls were run with acceptable results.The results of the correlation on both instruments were as follows: hba1c results: main g8 instrument, second g8 instrument: 11.9%, 10.9%.7.3 %, 7.3%.5.2%, 5.3%.6.0%, 6.0%.7.7%, 7.8%.14.3%, 14.6%.6.1%, 6.2%.6.0%, 6.1%.5.4%, 5.5%.6.1%, 6.2%.There was no indication of patient intervention or adverse health consequences due to the discrepant hemoglobin a1c results.

Manufacturer Narrative

Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number e2017013.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.Corrected data: a 13 month complaint history review and service history review for similar complaints was performed on serial number (b)(4 from (b)(6) 2018 through aware date (b)(6) 2019.There were no other similar complaints identified during the searched period.

• 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
• MDR Report Key: 8506848
• MDR Text Key: 152922067
• Report Number: 8031673-2019-00044
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• 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: 05/08/2019
• Distributor Facility Aware Date: 05/03/2019
• Device Age: 2 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/08/2019
• Date Manufacturer Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1