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

Model Number G8

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A 13-month complaint / service history review for similar complaints was performed for the serial number (b)(4) from aware date of (b)(6) 2018, which included data from (b)(6) 2017 through (b)(6) 2018.There were no similar complaints identified during the searched period, which includes this event.The g8 operator's manual under chapter 6 troubleshooting is as follows: 6.4 abnormal chromatograms from patients with hemoglobin variants or unknown peaks not recognized by the analyzer are occasionally seen during routine testing.These patterns may indicate interferences or problems with the assay.Therefore, it is important to use caution when troubleshooting.Review all chromatograms to determine whether the results are valid.In most cases, results for the sa1c% are reportable.In some cases, the sa1c% may be invalid depending on the hemoglobinopathy present, the flow rate, and the condition of the column and reagent system.The most likely cause of the reported event is attributed to an unidentified hemoglobin variant hbae for the patient in question that interferes with the g8 high performance liquid chromatography (hplc) methodology.

Event Description

A customer reported that one patient result had abnormal peaks with a hemoglobin a1c (hgba1c) result of 52.6% on the g8 analyzer.After reviewing the chromatogram, a technical support specialist (tss) informed the customer that the result was unreportable because of the presence of an unknown hemoglobinopathy.The customer was to send the result to a reference lab for testing.Tss followed up with the customer and confirmed that the doctor did not order a retest on this patient.The doctor had been made aware of the possible hemoglobinopathy and the patient was flagged to run future hgba1c by a method other than hplc.The customer stated that the flag 43 is installed on the analyzer and was active at the time this sample was run.This sample did not flag any variant hemoglobin.Tss asked the customer to check retention times on the other patients that were run the same day as this sample.The customer stated that the retention time on the sample in question was 0.55 minutes.The retention times on other patient samples ran on the same day were 0.59-0.60 minutes.

• Brand Name: TOSOH HLC-723GA 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 ; 6000 shoreline court; ste. 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7646106
• MDR Text Key: 112854415
• Report Number: 8031673-2018-00589
• 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: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• 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: 06/28/2018
• Distributor Facility Aware Date: 06/06/2018
• Device Age: 5 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/28/2018
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• 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