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

Model Number G8

Device Problems Use of Device Problem (1670); Device Ingredient or Reagent Problem (2910)

Patient Problem No Information (3190)

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

The problem of unmatched lots identified by the fse is due to operator error and can lead to abnormal chromatograms.Further investigation found that the customer had no matching f column on-site.The customer was provided instruction on how to eliquate and freeze controls for fresh use without being expired.Preventive maintenance was completed and controls and calibration performed were within acceptable limits.The most probable cause of the identified problem is related to operational error.The g8 service, operator's, and training manuals were reviewed and found to clearly address calibration, operation, maintenance, error codes and troubleshooting pertaining to the g8 system.Review of the g8 operators manual indicates: each master reagent lot number of g7 hsi elution buffers supplied by tosoh is performance matched to the corresponding tskgel g7 hsi variant columns.Column use cautions: always use the tskgel g8 variant hsi column in combination with the g8 variant elution buffer hsi of the identical lot number.Do not refill the elution buffer or use it without ensuring that the lot numbers are the same (first letter of buffer lot matches last letter of column lot).Abnormal chromatograms can be seen with unmatched lots.This report is being submitted due to a retrospective review conducted under capa(b)(4).

Event Description

On (b)(6) 2017, the customer called to schedule preventive maintenance for the g8 analyzer.On (b)(6) 2017, a tosoh field service engineer (fse) went to the customer site to perform preventive maintenance.During the on-site visit, the fse identified that the customer was using lot f reagents and lot d column.The customer indicated they are aware of the requirement to use the identical lot for reagents and column.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH BIOSCIENCES, INC.; 3600 gantz road; grove city OH 43123
• Manufacturer (Section G): TOSOH BIOSCIENCES, INC. (MANUFACTURER); 3600 gantz road; grove city OH 43123
• Manufacturer Contact: doria esquivel ; 6000 shoreline court suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7387812
• MDR Text Key: 104272276
• Report Number: 3005529799-2018-02203
• 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: 04/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2008
• 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