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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

On march 01, 2021, the technical support manager was contacted by the lab supervisor to discuss the discrepant results and requested a summary of the ticket in writing.The technical support manager informed the lab supervisor that 5% was right at the point of potential interference.Due to the unstable nature of the la1c portion of the glycohemoglobin, repeating the sample would have been standard practice.Also, when comparing a1c results especially with potential interference, knowing the method of comparison would be helpful.Lastly, there are clinical conditions that might influence the la1c, without that information, we would not be able to identify a problem cause for the discrepant result.A letter was sent to the customer on march 01, 2021.A 4-month complaint and service history review for serial number (b)(4) from installation date of (b)(6) 2020 through aware date of (b)(6) 2021 was performed for similar complaints.There were no similar complaints identified during the search period.The most probable cause of the reported event was due to operator error.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

Customer reported a patient result that was questioned by the physician.The customer's result was 5.7.The customer did not repeat the sample and was sent to another lab and the result was 8.5.The customer emailed chromatograph to technical support (ts), there are no errors or flags and the retention time for the sa1c is 0.59.Peak quality is very good as well.The la1c is high at 5.0%, if the la1c had been 5.1 the analyzer would have flagged the customer.Customer was unaware of the la1c rule of greater than 5% and will add that to the checklist for releasing 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: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 11572588
• MDR Text Key: 261044307
• Report Number: 8031673-2021-00061
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• 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
• Date Manufacturer Received: 02/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2020
• 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