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

Model Number G8

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) visited the customer to address the reported event.During the evaluation, fse reviewed quality control (qc) printouts which showed a 0.5% shift higher in the level 2 and level 3 on the biorad (br) qc.Fse checked for tightness in the fittings and found a loose collar for the small syringe.Fse also checked the entire instrument for proper tightness of fittings.Fse ran calibration and qc with acceptable results.A comparison study of 10 patients was ran between two analyzers and the results were within 0.1 of each other.The test count was 347 and the column count 519.The g8 instrument was operational.No further action was required by the fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.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: quality control- in order to monitor and evaluate the accuracy and precision of the analytical performance, controls should be assayed daily and after column replacement.Tosoh suggests running at least two levels of quality control material.The mean of one should be in the non-diabetic range (4-7% hba1c) with the second in the range of 9-12% hba1c.If the value of one or more control specimens is out of the acceptable range, recalibrate the system and rerun the controls before testing patient samples.The most probable cause of the reported event was due to loose collar on the syringe tip.

Event Description

A customer reported a shift in the quality control (qc) after preventative maintenance (pm) with the g8 instrument.The customer was running biorad (br) lot 38550.Prior to the pm, they were getting qc hba1c results of for 5.3% (range 4.67-5.71 with a mean of 5.1) for level 1, 9.3% (range 8.39-10.25 with a mean of 9.32) for level 2, and 13.3% (range 12.18-14.89 with a mean of 13.53) for level 3.After the pm, the hga1c qc results were 5.4% for level 1, 9.6% for level 2, and 13.9% for level 3.The customer reported that their qc established values were 5.2% +/- 1 standard deviation (sd) for level 1, 0.5, 9.3% +/- 1sd 0.2 for level 2, and 13.45% +/- 1sd 0.2 for level 3.The qc peer data was 5.23% +/-1sd 0.1 for level 1, 9.27% +/- 1sd 0.12 for level 2, and 13.35% +/- 1sd 0.18 for level 3.The customer reported that they recalibrated after the pm.The customer reported that even though the results were close to the mean and the shift up was slight, they have had to write letters in the past to the pathologist to explain the college of american pathologists (cap) proficiency results.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: 7594956
• MDR Text Key: 111450811
• Report Number: 8031673-2018-00535
• 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: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• 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: 06/12/2018
• Distributor Facility Aware Date: 05/24/2018
• Device Age: 3 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/12/2018
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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