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

For all 7 reported events, a field service engineer (fse) evaluated the analyzers at the customer sites and was able to confirm the pump unit errors.The fse replaced the pump components and assemblies for 6 of the 7 events.And for 1 of 7 events, the fse found air in lines which was flushed out.2 of 7 pumps were returned to instrument service center, and further confirmed pumps were faulty; 1 had a cam shaft fault and the other had faulty check valves.No additional issues have been reported by the facilities.All seven (7) g8 analyzers were repaired and returned to operational status.

Event Description

This report summarizes 7 malfunction events for the g8 analyzers.The review of events indicated that the g8 analyzer experienced pump error messages, which caused 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.

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.For 1 of the 7 reported events, the check valve uptake was returned to tosoh instrument service center for investigation.Functional testing confirmed the reported failure was due to a partially occluded check valve and led to high retention times.Probable cause of the reported event was a failure of the uptake check valve due to partial occlusion of uptake check valve.

Manufacturer Narrative

Device evaluation by manufacturer: for a 2nd event out of the four (4) reported events, the check valve uptake and check valve purge were returned to the instrument service center for evaluation.Visual inspection confirmed no physical damage.During functional testing both parts passed.The reported event could not be duplicated.The most probable cause of the reported event could not be determined.

• 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
• MDR Report Key: 8550797
• MDR Text Key: 146531957
• Report Number: 8031673-2019-00111
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 7
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Patient Sequence Number: 1