MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8; G8, PRODUCT CODE: LCP

Model Number G8

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

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

Event Date 11/09/2015

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted due to a retrospective review conducted under (b)(4).On (b)(4) 2015 a technical support specialist (tss) spoke with the customer over-the-phone to address the reported event.The tss assisted the customer and determined the customer recalibrated and adjusted the flow factor on only one of the systems.Ts advised the customer to recalibrated the other g8 system.No further information was available.The probable cause of the event was user technique.

Event Description

On (b)(6) 2015 a customer reported different patient results when comparing two g8 analyzers.The customer was unable to run samples and requested service to address the reported event.There was no indication of any patient intervention or adverse event consequence due to the delay of reporting patient results.Patient results reported: 12.0 versus 12.5; 12.1 versus 12.5; 10.5 versus 10.2; 10.9 versus 11.3.And 6.6 versus 6.7; 6.0, versus 6.1; 6.0 versus 6.2.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8, PRODUCT CODE: LCP
• 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 (MANUFACTURER); 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: 7432059
• MDR Text Key: 106144670
• Report Number: 8031673-2018-04763
• 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: 04/16/2018

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: 04/16/2018
• Distributor Facility Aware Date: 11/09/2015
• Device Age: 14 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/16/2018
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2001
• 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