MAUDE Adverse Event Report: TOSOH HI-TEC TOSOH HLC-723G8 ANALYZER

Model Number G8

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 01/27/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the customer's sample in tosoh's qa lab confirmed the customer's results.The g8 variant analysis mode operator's manual under chapter 1, introduction and applications, states that the level of la1c changes rapidly in response to changes in blood glucose concentration.However, the level of the sa1c does not fluctuate significantly in response to physiological factors.Consequently, the sa1c measurement provides a better indication of the average glucose level over the previous two to three months (the average red blood cell life span).A review of the information provided by the customer showed that the column count was at 3001 injections, which exceeded the 2500 injection count recommended by tosoh bioscience, inc.Root cause for the reported event could not be determined.(b)(4).

Event Description

On (b)(6) 2017 the customer reported results for sa1c of 5.2%, la1c of 5.1 % (above reportable range), and glucose of 244 mg/dl.The customer reported that the normal sa1c result of 5.2% did not match the patient's clinical history, which was typically higher.The customer was advised to send the specimen for testing with an alternative method; the specimen was sent out to be tested on roche's integra immunoturbometric methodology.On (b)(6) 2017 the customer reported that the test that was sent out to be tested on roche's integra immunoturbometric methodology had a sa1c result of 8.4%.The customer provided the chromatograms and upon review it was determined that further testing by tosoh's quality assurance (qa) lab would be required.The patient was currently on the following medication: betamethasone - dipropionate, ombivent respimat, metforman hcg extended release, pro-air hfa 108, simbacort, lidocaine mouth rinse.The customer confirmed that the sa1c of 5.2% result was reported out of the lab and questioned by the physician, because it was inconsistent with the patient's profile.On (b)(6) 2017 the customer called back to discuss tosoh's qa lab findings, which confirmed that the specimen ran in qc correlated with their result.The customer did question why there was a difference with the integra immunoturbometric methodology.The customer stated that the patient has not been in the clinic again for another ha1c test.

Manufacturer Narrative

Device evaluation by manufacturer: a 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 27-dec-2015 through 27-jan-2017.There were no other similar complaints identified during the searched period.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 HI-TEC; 1-37 fukugawa minami-machi; shunan-shi 746-0042, ja, ; JA
• 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: 6792860
• MDR Text Key: 84344188
• Report Number: 8031673-2017-00006
• 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: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• 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: 12/27/2017
• Distributor Facility Aware Date: 01/27/2017
• Device Age: 9 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/27/2017
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2008
• 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