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

Model Number G8

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Issue (2379)

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

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

A complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 14-apr-2017 through aware date 14-may-2018.There were no similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: abnormal chromatograms: although the percentage of each hemoglobin component may vary slightly from patient to patient, most whole blood samples will contain six fractions: a1a, a1b, f, la1c+, sa1c, and a0.A normal chromatogram is shown below in figure 6-2.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.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 tosoh automated glycohemoglobin analyzer hlc-723g8 has known hemoglobin e (hbe) interference.When a sample is suspected to contain hbe a flag will be displayed.The hba1c result will not be reported from the analyzer.Flag code 43 can be used to detect the presence of a p-hv3 peak where the hbe variant typically elutes.(see chapter 4, section 4.18 "flag parameter setting" for a description of flag settings).Glycemic monitoring for patients displaying any homozygous hemoglobin other than hbaa such as hbss, hbcc or the double heterozygous hbsc, cannot be performed using sa1c because there is no hba present.Alternative testing is mandatory for these types of patients.The most likely cause of the reported event is attributed to an identified hemoglobin variant hbae for the patient in question that is known to interfere with the g8 high performance liquid chromatography (hplc) methodology.(b)(4).

Event Description

A customer reported a hemoglobin a1c (hba1c) result of 53.1% on a patient result with the g8 analyzer.The customer provided a copy of the chromatograph for review, which showed no flags or errors were generated on the patient result.The customer reported that all patient samples that were run before and after were normal.The technical support specialist (tss) explained to the customer that the patient in question has a hemoglobin variant hbae and would need to be tested by another method for the hba1c.The tss recommended that a hemoglobin gel electrophoresis (hb elp) test should be performed on the patient sample in question to clarify the hemoglobinopathy.The customer reported that the patient sample in question was obtained at a health fair and did not have any further information on the patient's medical history.On (b)(6) 2018, the customer reported that the patient sample in question was tested for hba1c on the vista analyzer and the result was 5.3%.Customer also indicated that the doctor running the clinic has been informed about the patient's possible hemoglobin variant hbae.There was no indication of any patient intervention or adverse health consequences due to this 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
• 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: 7599078
• MDR Text Key: 111441015
• Report Number: 8031673-2018-00495
• 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: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 06/13/2018
• Distributor Facility Aware Date: 05/14/2018
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2018
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2010
• 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
• Patient Age: 34 YR