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

Model Number G8

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

Field service engineers (fse) evaluated 10 of the 16 events at the customers' sites.Two of the 16 events were evaluated by the fses over-the-phone with the customers.Four (4) of the 16 events were evaluated by technical support over-the-phone with the customers.Evaluation of all 16 events determined that the reported events were due to operators not following the manufacturer's instructions per the operator's manual.The g8 analyzers were repaired and returned to operational status.

Event Description

This report summarizes 16 malfunction events on the g8 analyzer.The review of these events indicated that the g8 analyzers experienced multiple error messages during sample/quality control operation, which caused delayed reporting of hemoglobin a1c (hba1c) patient results.These reports were received from various sources.Of the 16 events, 3 events involved patient samples with no indication of patient intervention or adverse health consequences due to the delayed reporting in patient test results.None of these events necessitated remedial action to prevent an unreasonable risk of substantial harm to the public health.

Manufacturer Narrative

H.11 corrected data: for corrected data, please refer to section g.5.Pma/510(k).

• 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: 8552821
• MDR Text Key: 146531943
• Report Number: 8031673-2019-00126
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 16
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G8
• Device Catalogue Number: 021560
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 06/29/2019
• Supplement Dates FDA Received: 07/02/2019
• Patient Sequence Number: 1