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

Model Number G8

Device Problems Low Readings (2460); Inadequate User Interface (2958)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2016

Event Type  Injury  

Event Description

On (b)(6) 2016: tosoh bioscience was notified that an hba1c result from the tosoh bioscience g8 analyzer had been reported as a result of 3.6%.The column count (2463) was within acceptable range and the qcs were acceptable.The analyzer was performing as expected.The specimen was repeated and the result was 8.1%, which was expected based on previous results.No treatment was performed based on the initial low result.The investigation of the incorrect result indicated that the customer uses auto verification of results and the chromatograms are not reviewed.The chromatogram for the incorrect result had a shoulder attached to the a0 peak which if reviewed should have indicated a non-reportable result.Tosoh bioscience recommends a review of the chromatograms before results are reported.Root cause: operator error.Chromatogram was not reviewed prior to result being released.

Manufacturer Narrative

Corrected data/ addl information: patient identifier, adverse event or product problem, outcomes attributed to adverse event, date of event, event,relevant tests/laboratory data, brand name, manufacturer name, city and state, operator of device, initial reporter health professional, initial reporter occupation, e4, f3, f4, f5, f6, f11, f12, f14.Mfr site 2: contact office: (b)(4) g1, 2: manufacturing site: tosoh corporation (manufacturer) shiba-koen (b)(4) g7: follow up #1 h1: malfunction h2.Correction h3: yes h4, 08/01/2011 h5.No h6: patient code: 2692; no known impact or consequence to paient device code: 2456; incorrect or inadequate test results method code:3263; actual device not evaluated results code:114; operational problem conclusion code: 19; human factors issue h8: reuse h10.The most probable cause of the reported event was due to operator error.Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number e2017013.This report is being submitted due to a retrospective review conducted under capa(b)(4).Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.

Event Description

On (b)(6) 2016, the customer called to report low patient hba1c results (3.6%) on their g8 analyzer.The specimen was repeated and the result was (b)(4) , which was expected based on previous results.The reported result was modified after receiving the second result.The column count and quality control (qc) were reported to be within acceptable ranges.No intervention was performed; however, technical support (ts) recommended that the customer use recommended flags (auto-verify) and that they review all chromatograms prior to reporting.Ts faxed the customer a list of recommended flags for future reference.The reported event resulted in discrepant hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.No further issues were noted.No further action was required.

• 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: 6219593
• MDR Text Key: 63769584
• Report Number: 3005529799-2016-00019
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: Yes
• 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: 04/11/2018
• Distributor Facility Aware Date: 12/15/2016
• Device Age: 5 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other