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

Model Number G8

Device Problem Detachment Of Device Component (1104)

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

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was dispatched to address the reported event.On 24-feb-2016, fse arrived at the site to replace the peek tubing at the tube line filter.No further issues were reported and no further action was required from field service.The most probable cause of the reported event was due to broken peek tubing for the tube line filter.(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).

Event Description

A customer in the (b)(6) contacted biomérieux to report a misidentification of actinomyces species in association with the vitek® ms system.Vitek ms obtained the following results for three tests: spot k2: single choice to streptococcus anginosus; spot k3: single choice to streptococcus constellatus; spot k4: single choice to actinomyces meyeri.Testing via alternate method (bruker) obtained actinomyces odontolyticus.Reference method testing (e.G.Sequencing) was not performed.The customer stated that the vitek ms results were not reported to the treating physician and had no impact on patient treatment decisions.There have been no adverse impact on patient health.Based on review of the mzml log files and calibration logs, preliminary analysis indicates the customer's slide spot preparation is non-optimal and heterogeneous; hence the inconsistent organism identifications.In addition, the fine-tuning of the instrument does not meet all specified criteria.Biomérieux investigation has been initiated to perform vitek ms instrument fine-tuning and provide additional spot preparation training for the customer.This will be followed by testing of the same specimen to monitor for consistency and accuracy of result.

• 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 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; 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: 7329823
• MDR Text Key: 102337716
• Report Number: 8031673-2018-01970
• 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: 03/11/2018

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: 03/11/2018
• Distributor Facility Aware Date: 02/23/2016
• Device Age: 5 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/11/2018
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2011
• 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
• Patient Outcome(s): Death