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

Model Number G8

Device Problem Device Operational Issue (2914)

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

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (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.However, while traveling to the facility, fse received a phone call that the issue has been resolved.The customer found the waste line was pinched, causing the low total area on the chromatogram of the instrument.The customer cleared the waste line and now is getting normal total area that is within the acceptable range (the acceptable range is 500-4000; optimal range is 700 to 3000).The g8 instrument is functioning as intended and no action is required from field service.A 13-month complaint history review and service history review for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018 for similar complaints was performed.There were two (2) 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 addition, chapter 3 assay operations, under detailed peak information, the optimal range for total area is 700 to 3000.The most probable cause of the reported event was due to pinched waste line.

Event Description

On (b)(6) 2018, customer reported getting low total area (ta) flag (the acceptable range is 500-4000; optimal range is 700 to 3000) on the g8 instrument.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
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• 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: 7405476
• MDR Text Key: 105172105
• Report Number: 8031673-2018-00284
• 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: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2018
• Distributor Facility Aware Date: 03/13/2018
• Device Age: 8 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/06/2018
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: No
• 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