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

Model Number G8

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(4) 2016, technical support specialist (tss) addressed the event with the customer over the phone.After requesting the data from the customer and evaluating it, the tss observed that the chromatograms had "check peak" flags.Check peak flags indicate that a possible hemoglobin variant may be present in the sample or there may be an instrument problem.They are intended to alert that unknown peaks were detected, and that the results should be evaluated before reporting.Also, the chromatograms had different retention times listed as prior to the ao also making the result again non-reportable.The tss explained the operator about the meaning of "check peak" flags and of peaks eluting prior the ao to the operator and suggested additional training.The incorrect result reported for this patient sample was due to customer reporting a result that was clearly defined as non-reportable per tosoh training manual and interpretation guide.No further actions were required by technical support services.The most probable cause of the reported event was a combination of a specimen with a hemoglobin variant that caused interference and made the results non-reportable and the operator needed additional training.(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).

Event Description

On (b)(6) 2016, a customer called to report a peak pattern issues that was obtained with their hlc-723g8 analyzer.The results were sent to the physician who questioned the results, and the sample was then sent to an external facility for further testing not confirming the initial values.The customer reported discrepant hba1c patient samples.The representative from the technical support specialist (tss) spoke to the customer to address the reported event which resulted in discrepant results.There was no indication of patient intervention or adverse health consequences due to the discrepant result reported.

• Brand Name: TOSOH HLC-723G8 ANALYZER
• 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: 7347639
• MDR Text Key: 103167791
• Report Number: 8031673-2018-01698
• 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: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2018
• Distributor Facility Aware Date: 12/19/2016
• Device Age: 6 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/16/2018
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2011
• 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