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 Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated 1 of the 2 events at the customer's site.1 event was evaluated by the fse over the phone with the customer.The fses were able to confirm the reported events and resolved the issue by adjusting the flow rates on the analyzer.No additional issues have been reported by the facilities.The two (2) g8 analyzers are in service.

Event Description

This report summarizes 2 malfunction events for the g8 analyzer.The review of events indicated that the g8 analyzer experienced retention time error messages, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).These reports were received from various sources.There was no indication of patient intervention or adverse health consequences due to the delayed reporting in patient results.None of these events necessitated remedial action to prevent an unreasonable risk of substantial harm to the public health.

• 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, japan 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586-23 ; JA 1058623
• MDR Report Key: 8550768
• MDR Text Key: 146090040
• Report Number: 8031673-2019-00106
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1