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 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A customer contacted tosoh in regards to stable a1c (sa1c) results on patient samples generated with their two (2) g8 analyzers in comparison with results on the siemens dca advantage analyzer (refer to associated mfr report #: 8031673-2018-00946 / (b)(4)).The customer reported running all g8 sa1c patient results with identified hb variants on the dca advantage analyzer in response to the urgent medical device recall letter 2018-006 and requested that tosoh verified whether issue was associated to the event reported under this letter.The patient results provided were as follow: (b)(6).A review of the data provided by the customer showed no hba1c patient results due to flag 40 being generated by the g8 analyzer, which indicates one or more h-v0, h-v1, and h-v2 peaks being detected.These peaks are associated with (b)(6) variants.The customer's medical director has requested that all patient samples with identified (b)(6) variants be repeated on the dca advantage analyzer; not just the ones over 9.0%.The customer understood that only the patient samples above hba1c >9.0% have a clinically significant bias.The customer has chosen to send all patient samples with presence of (b)(6) variants and no interference for testing to reference lab.There is no indication of any adverse health consequences or medical intervention as a result of this event.

Manufacturer Narrative

Additional manufacturer narrative: a 13-month complaint history review and service history review was performed on serial number (b)(4) for similar complaints from 01-sep-2017 through aware date 01-oct-2018.There were no other similar complaints identified during the search period.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: abnormal chromatograms: 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.Chapter 4, screen operations, states the following: flag 40: report if one or more of h-v0, h-v1 and h-v2 peaks was detected.The most probable cause of the reported event could not be determined.The customer has chosen to send all patient samples with presence of hb variants and no interference for testing to reference lab.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: 8026994
• MDR Text Key: 127253281
• Report Number: 8031673-2018-05247
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• 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: 09/13/2019
• Distributor Facility Aware Date: 09/13/2019
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2019
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2018-006
• Patient Sequence Number: 1