MAUDE Adverse Event Report: TOSOH HI-TEC TOSOH HLC-723G8 ANALYZER

Model Number G8

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the information provided by the customer confirmed that the retention time and hba1c were within normal ranges.The data provided thus far indicates no product issue; however, it is not known whether the hba1c patient result correlates with the patient's clinical history.It is also not known whether the customer sent the specimen for further confirmation.(b)(4).

Event Description

On (b)(6) 2017 a customer questioned whether an hba1c result with a slight area in the front peak could be reported out of the lab.The customer reported that the sa1c retention time was 0.59 (ideal range) and the patient had an hba1c result of 4.8% (normal ranges 4.0-6.0%).The customer was informed that the front peak is not used in the calculation of the hba1c, as specified in the g8 operator's manual.The customer was advised that if the result was of any concern, to send it out for further confirmation.The tosoh technical support specialist provided additional training with interpretation of chromatograms.No further information was provided by the customer.No confirmation of whether hba1c result correlates with the patient's clinical history or whether specimen was sent out for further analysis.

Manufacturer Narrative

Device evaluation by manufacturer: a 13-month complaint history review and service history review for similar complaints was performed for the g8, serial number (b)(4), from (b)(6) 2016 through (b)(6) 2017.There were no other similar complaints identified during the searched period.The g8 variant analysis mode training manual under lesson 5, interpreting results, states: it is very important that the operator review the chromatograms before reporting results.Chromatograms should contain six peaks and have sharp la1c and sa1c peaks.Mathematical algorithms used in the software exclude variant peaks eluting after the a0 peak when calculating the total area.The sa1c% is usually not affected in such situations, although chromatograms should be carefully reviewed.Hbs, hbd and hbc elute after the a0 peak.The sa1c% is generally reportable on the g8 when these hemoglobins are present in the heterozygous state with hba.The most probable cause of the reported event could not be determined.Report source: under the above section "user facility" was incorrectly selected.The only report source is "health professional".

Event Description

N/a.

• Brand Name: TOSOH HLC-723G8 ANALYZER
• Type of Device: G8
• Manufacturer (Section D): TOSOH HI-TEC; 1-37 fukugawa minami-machi; shunan-shi 746-0042, ja, ; JA
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC. (IMPORTER); 6000 shoreline court; suite 101; south san francisco CA 94080
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 6817427
• MDR Text Key: 83748627
• Report Number: 8031673-2017-00015
• 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,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2017
• Distributor Facility Aware Date: 07/25/2017
• Device Age: 9 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/28/2017
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2008
• 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