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

Model Number G8

Device Problem Device Operational Issue (2914)

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

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).Device by manufacturer: on 3-dec-2015, an fse was dispatched to the customer facility to address the reported event.Fse began to troubleshoot the issue.Fse verified the issue and replaced rotor seal and stator face, 6-way valve seal, and small syringe.Fse verified proper operation.The customer ran quality control (qc) in which all results were within acceptable range and verified that the analyzer was functioning correctly.The g8 analyzer was functioning as intended and the errors cleared.No further action required by field service.The probable cause of the event was rotor seal and stator face seal.

Event Description

On (b)(6) 2015, a customer reported low ta on br qc, always on first diluted sample run, cc=2234 with their g8 analyzer.Using liquid br control, went over how control is made up.Controls opened on (b)(6) 2015, total area was low on l1, customer added more control to the cup and "it worked".Asked customer to use 10 ul and add 2 mls of fresh h and w.Using tosoh cups in rack and using bc adapter, went over how high cup is sitting in rack.Followup, l1 ta=430, l2=845.Thawing new qc1 now, will repeat test.Followup, customer changed the order that was run in, ran l2 first, then l1.Now l2 has a low ta, l1 ran ok on the newly made vial.Customer moved the controls deeper into the rack, seems like whatever is in the first sampling position ends up with a low ta (when run as a diluted sample).Whole bloods run after qc, all have acceptable tas even the first sample run.Cc=2234.The customer is unable to run hba1c patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• 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
• 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: 7401830
• MDR Text Key: 104896241
• Report Number: 8031673-2018-04163
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/05/2018

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: Health Professional
• Device Model Number: G8
• Device Catalogue Number: G8: 021560
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2018
• Distributor Facility Aware Date: 11/19/2015
• Device Age: 11 MO
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/05/2018
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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