MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. G7

Model Number G7

Device Problem Device Contamination With Biological Material (2908)

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

Event Date 03/14/2016

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted due to a retrospective review conducted under capa-(b)(6).There is no documentation of when the fse visited the customer site.The complaint indicates that the fse tried different reagents to rule out reagent contamination unsuccessfully.The ticket indicates that after decontaminating system the variant peak disappeared and now reporting and operating properly with good control values.No additional information was provided.A review of complaint history for the next four (4) months the after this ticket was opened did not identify any further assistance requested by the customer, therefore, no further action required by field service.The most probable cause of the reported event was due biological contamination of system.

Event Description

On (b)(6) 2016, a customer contacted the distribution center due to obtaining peaks of unknown origin,- hb-var detect alarms and it was detecting an h-v1 peak in all samples processed.The customer was unable to run hba1c patient samples.A field service engineer (fse) from a distributor was dispatched to address the reported event, which resulted in delayed reporting of hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• Brand Name: G7
• Type of Device: G7
• 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 ; 6506368126
• MDR Report Key: 7437131
• MDR Text Key: 106259200
• Report Number: 3005529799-2018-05102
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K011434
• 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: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G7
• Device Catalogue Number: 019327
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 3 YR
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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