MAUDE Adverse Event Report: TOSOH HI-TEC TOSOH HLC-723G8 ANALYZER

Model Number G8

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2017

Event Type  malfunction  

Manufacturer Narrative

Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation per exemption number (b)(4).

Event Description

On (b)(6) 2017 customer using a tosoh g8 reported that two patient hba1c results from the same run were sent to the host lis that were incorrect and the results were then reported to the physician.One result was questioned by the physician: patient 1 hba1c = 1.3%, patient 2 hba1c = 3.2%.On (b)(6) 2017 tosoh bioscience notified of the incorrect patient results being released to the physician.Customer indicated that the g8 column count = 7059 (which is over the recommended 2500 column count).Hba1c qc results were within target range.When tosoh bioscience technical support specialist reviewed the chromatograms for the reported results the chromatograms did not meet parameters for acceptability.The chromatograms had elevated baselines and multiple missing peaks which indicated that the results were not reportable but had been released without having the required chromatogram review by the technologist.The expired column was replaced with a new column, qcs and patient specimens were repeated.Qcs and patient specimen chromatograms had all peaks present, correct baseline re-established, and correct system pressure maintained per new column inspection report.Root cause: g8 column count exceeded recommended column count.

• Brand Name: TOSOH HLC-723G8 ANALYZER
• Type of Device: G8
• Manufacturer (Section D): TOSOH HI-TEC; 1-37 fukugawa minami-machi; shunan-shi, 746-0 042; JA 746-0042
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city OH 43123
• Manufacturer Contact: susan koss ; 3600 gantz road; grove city, OH 43123 ; 6143171909
• MDR Report Key: 6579818
• MDR Text Key: 75786614
• Report Number: 8031673-2017-00002
• 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,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• 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: 05/19/2017
• Distributor Facility Aware Date: 04/20/2017
• Device Age: 1 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/18/2017
• Date Manufacturer Received: 04/20/2017
• Date Device Manufactured: 04/01/2016
• 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