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

Model Number G8

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900); Device Operational Issue (2914)

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

Event Date 10/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On 16-oct-2017 a field service engineer (fse) followed-up with the customer over-the-phone for troubleshooting.During troubleshooting the customer found that the syringe-s (small syringe) hex bolt and nut were loose.The customer tightened the hex bolt and nut on the syringe-s.The instrument was performing within specifications after completing the repair.A 13-month complaint history review and service history review for similar complaints was performed for serial (b)(4) from 13-sep-2016 through (b)(6) 2017.There were two (2) similar complaints identified during the searched period, which includes this event.The g8 operator's manual under chapter 1 - introduction and applications, states that dilution studies demonstrate that the assay is linear from a total area of 500 to 4000.However, the optimum total area is 700 to 3000.Results will not be reported if the total area (ta) is <500 and if the ta is >4000.The most likely caused of the reported issue was due to loose hex bolt and nut on the small syringe.

Event Description

On (b)(6) 2017 a customer reported getting low total areas flags while running hemoglobin a1c (hba1c) on patient samples with the g8 instrument.The customer reported not getting a1c results due total area of 300 to 400.The customer reported that total area on quality controls was within normal range.The customer is unable to run patient samples on hba1c.On 16-oct-2017 a field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hba1c.There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

(b)(4) per exemption number e2017013.Report source: under the above section "user facility" was incorrectly selected.The only report source is "health professional".

Event Description

N/a.

• Brand Name: TOSOH HLC-723G8 ANALYZER
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, 105-8 623; JA 105-8623
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC. (IMPORTER); 6000 shoreline court; suite 101; south san francisco CA 94080
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7023217
• MDR Text Key: 92760010
• Report Number: 8031673-2017-00102
• 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,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2017

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2017
• Distributor Facility Aware Date: 10/13/2017
• Device Age: 3 MO
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/29/2017
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 10/13/2017
• Supplement Dates FDA Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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