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 03/16/2018

Event Type  malfunction  

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 event.Fse confirmed the low area from chromatogram printouts of the g8 instrument.Fse suspected the sample needle was partially occluded and replaced it with a new needle.Fse then ran 20 patient samples and the total area resulted within acceptable range, between 1300 and 1700 (the acceptable range is 500-4000; optimal range is 700 to 3000).Fse ran quality controls (qc); all results were within acceptable range and the g8 instrument function as intended.On (b)(6) 2018, fse returned to the customer's facility to address the persisting low total area reported by the customer on the same day.Fse verified the low areas with patient chromatogram printouts and replaced the small volume syringe.The chromatograms show total area is now between 1300 and 2000 (the acceptable range is 500-4000; optimal range is 700 to 3000).Fse then ran quality controls (qc) and racks of patient samples as performance verifications.All results passed, the total area is within the optimal range of 700 to 3000 and qc results were within acceptable range.The g8 instrument functions as intended.No further action required from field service.A 13-month complaint history review and service history review for serial number (b)(4) from 16-feb-2017 through aware date 15-mar-2018 for similar complaints was performed.There were no 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 defective small syringe.

Event Description

On (b)(6) 2018, a customer reported getting low total area (the acceptable range is 500-4000; optimal range is 700 to 3000) with whole blood specimens on the g8 instrument.Customer stated the issue persisted despite changing the sample needle.On (b)(6) 2018, 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.

Manufacturer Narrative

Device evaluation by manufacturer: the g8 analyzer's syringe unit (part # 021794) was received at instrument service center (isc) for in-house investigation.Isc investigation verified the syringe unit is defective.Visual inspection showed the syringe mounting screw was sheared off, contributing to the reported complaint.The most probable cause of the reported event was due to the syringe mounting screw was sheared off.Corrected data in the initial report stated: fse was dispatched on 19-march-2018 and 23-march-2018.The corrected date is 16-march-2018.

Event Description

N/a.

Manufacturer Narrative

One sampling needle assembly was returned for evaluation to the tosoh instrument service center (isc) with no shipping damage.The sampling needle assembly passed functional testing.The reported event was not duplicated.The most probable cause of the reported event remains the same; the syringe mounting screw was sheared off resulting in the reported event.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
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• MDR Report Key: 7431891
• MDR Text Key: 105878877
• Report Number: 8031673-2018-00309
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2018
• Distributor Facility Aware Date: 04/02/2018
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/04/2018
• Date Manufacturer Received: 04/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1