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

Model Number G8

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: (b)(4).Device evaluation by manufacturer: on (b)(6) 2018, a field service engineer (fse) was dispatched to the customer's facility to address the reported issue.Fse ran controls and observed low areas.Fse found air was entering the sampling system, causing the reported issue.Fse checked rotor seal and stator face, removed fittings on rheydyn valve face plate and flushed ports to make sure they are clear.Fse replaced small syringe due to possible failure to draw sample.Fse replaced sample needle due to air entering system between needle and rheydyn valve.Fse calibrated and ran quality controls (qc) and patient samples.All results and total areas were within acceptable range.The g8 instrument is functioning as intended.No further actions required from field service engineer.A 13-month complaint history review and service history review for serial number (b)(4) from 01-feb-2017 through aware date (b)(6) 2018 for similar complaints was performed.There were no other similar complaints identified during the searched period.The g8 operator's manual under chapter 1, introduction and application, under interpretation of results, provides guidance on the total area and chromatography.Paragraphs three to five state " results will not be reported if the total area (ta) is <500 which can be seen in severe anemia.Results will not be reported if the ta is >4000 which can be seen in polycythemia.(see "abnormal red cell survival in previous section).The optimal goal for total area is between 700-3000.However a ta in the range of 500-4000 is acceptable and reportable for whole blood specimens.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.When there is a question concerning the chromatography, repeat the sample.If the repeated sample also displays unusual characteristics, it is appropriate to evaluate whether the unusual result is due to an abnormal sample, a procedural error, an instrument malfunction or a sample-handling problem.For further information, see the troubleshooting section in this operator's manual." in chapter 6 - troubleshooting states, 200 area low error is generated when three successive results below the lower limit of the total area (50) occur.If the error message is present when sufficient volume of sample is set in the rack, the problem may be caused by an empty reagent (hemolysis & wash solution).Operator is instructed to check the remaining volume of hemolysis & wash solution and start the assay again.The most probable cause of the reported event was due to air leaking into sampling system.

Event Description

On (b)(6) 2018, customer reported getting 200 low total area (ta; the total area optimal range is 700 to 3000) during quality controls (qc) run on the g8 instrument.Customer noted changing the controls, but was still getting low total area.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• 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, japan 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6509368123
• MDR Report Key: 7380223
• MDR Text Key: 103951180
• Report Number: 8031673-2018-00239
• 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: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2018
• Distributor Facility Aware Date: 03/01/2018
• Device Age: 8 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/28/2018
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• 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