MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. TOSOH HLC-723G8 ANALYZER G8

Model Number G8

Device Problems Loose or Intermittent Connection (1371); No Pressure (2994)

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

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A field service engineer (fse) followed up with customer over the phone.Fse was informed by the customer that the analyzer's peek tubing had sprung loose from fitting on the top of the filter housing.The customer had attempted to reattach it but fitting was loose and kept spinning.Fse instructed the customer to tighten down wingnut filter housing to get the fitting stationary.The customer followed up with fse the following day to inform him that their instrument tech was successfully able to get the tube reattached.No further action required by field service.The g8 analyzer is functioning as expected.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4).There were no similar complaints identified during the search period.The g8 operator's manual under chapter 5, maintenance procedures, provides detailed information on how to replace the filter and tighten tubing around it.The most probable cause of the reported event was due to disconnected tubing from filter housing.

Event Description

A customer reported disconnected tubing to the prefilter and no pressure on the g8 analyzer.Technical support specialist (tss) instructed the customer to remove the brown screw from the filter housing and place onto the tubing and then reattach to the filter housing.The customer was unable to remove the screw on the filter housing.The customer followed up and stated the ferrule will not completely screw into the wing nut, the wing nut and filter housing keep spinning.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 G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city OH 43123
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC. (MANUFACTURER); 3600 gantz road; grove city OH 43123
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6509368123
• MDR Report Key: 8087560
• MDR Text Key: 129193628
• Report Number: 3005529799-2018-05251
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2018
• Device Age: 2 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 11/19/2018
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2016
• 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