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 Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: no conclusion is yet available; investigation is currently in-process.(b)(4).

Event Description

On (b)(6) 2018, a customer questioned whether a patient result for hemoglobin a1c (hba1c) of 6.8%, with hemoglobin variant flag and two (2) p00 peaks after the a0 peak on the g8 instrument, could be reported out of the lab.The customer ran the same patient sample on an arkray instrument and obtained an hba1c result of 7.3%.The customer stated that previous tests on this particular patient had been sent out to a reference lab and the last one had an hba1c result of 7.1%.No adverse effect to patient management was reported due to this event.

Manufacturer Narrative

The technical support specialist (tss) reviewed the chromatograms provided by the customer.The tss confirmed that the subject patient result was reportable.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 26-feb-2017 through aware date 26-mar-2018.There were no other similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 1, introductions and applications, states the following: the chromatogram must be examined for any unidentifiable peaks (i.E., p00, p01,) before the a0 peak.Do not report the result if these peaks exist.The g8 variant analysis mode training manual under section 10, programming analyzer flags, states the following: code 40: code 40 relates to variant peaks detected after the a0 peak.These peaks are designated as h-v0, h-v1 or h-v2.This flag will be generated when one or more variant peaks are detected.Suggestion for programming flag: 40=0 0.Hb-var detect: a possible variant may be present in the sample when this flag is generated.The most probable cause of the reported event was due to a possible variant present in the subject patient sample.The g8 instrument functioned as designed by alerting the operator of the abnormal patient result.Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number e2017013.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.

• 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 105-8 623; JA 105-8623
• MDR Report Key: 7449169
• MDR Text Key: 106852262
• Report Number: 8031673-2018-00340
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2019
• Distributor Facility Aware Date: 02/06/2019
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2019
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1