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

Model Number G8

Device Problem Device Operational Issue (2914)

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

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: on (b)(4) 2018, a field service engineer verified the reported issue of low total areas on quality controls (qc) and calibrators.The fse replaced the sampling needle assembly, tightened the loose screws on both the large and small syringes, and tightened the tubing 1-6 at the injection valve and prefilter assembly.The fse ran calibrations, qc, and patient samples without any further issues.The g8 was performing within manufacturer's specifications; no further action was required by the fse.A (b)(4) complaint history review and service history review for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018 for similar complaints was performed.There were no other similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 1, introduction and applications, states the following: the 1.8 limitations of the procedure: total area 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.Interpretation of results: results will not be reported if the total area (ta) is <500 which can be seen in severe anemia.Results will not be reported if the ta is >4000 which can be seen in polycythemia.(see "abnormal red cell survival in previous section).The optimal goal for total area is between 700-3000.However a ta in the range of 500-4000 is acceptable and reportable for whole blood specimens.Chapter 5, maintenance procedures, provides step-by-step instructions for replacement of the sampling needle assembly.The most probable cause of the reported issue was due to a clogged sampling needle assembly.(b)(6).

Event Description

On (b)(6) 2018, a customer reported getting low total areas while running quality controls (qc) and calibrators on the g8 instrument.The technical support specialist (tss) instructed the customer to prime the reagents and wash solution and check for kinks on the waste line.The tss had the customer run qc, which resulted with low total area.The tss had the customer run 2 whole blood primers, which resulted with low total areas as well.The tss advised the customer to replace the sampling needle assembly, but the customer did not have a replacement onsite.The tss sent a replacement sampling needle assembly and 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 is 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 CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 105-8 623; JA 105-8623
• 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: 7444749
• MDR Text Key: 106627465
• Report Number: 8031673-2018-00316
• 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: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2018
• Distributor Facility Aware Date: 03/20/2018
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2018
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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