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

Model Number G8

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.Device evaluation by manufacturer: a field service engineer (fse) visited the customer to address the reported event.During the evaluation, fse confirmed the problem.To resolve the issue, fse adjusted the sys-in1 parameter from 128 to 119.Fse then ran a full rack of whole blood patient samples and all total area values were less than 2000.Fse ran quality controls (qc) with acceptable results.The instrument was operating as expected.There was no further action required by fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 13-aug-2017 through aware date 13-sept2018.There were no similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 1, introduction and applications, states the following: 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.The most probable cause of the reported event was due to misalignment fo the sys-in1 parameter setting.

Event Description

A customer reported that several whole blood specimens have had total areas of greater than 4000 on the g8 instrument.The customer stated that the normal total areas they had been getting were on average 3000 when the total areas were previously 1500.The quality controls (qc) total areas were also higher than normal.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 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; 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: 7943379
• MDR Text Key: 123963823
• Report Number: 8031673-2018-00897
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2018
• Distributor Facility Aware Date: 09/13/2018
• Device Age: 5 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 10/08/2018
• Date Manufacturer Received: 09/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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