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

Model Number G8

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

The g8 variant analysis mode operator's manual under chapter 3, assay operations, sub-section 3.6 - calibration, indicates to calibrate when the control assay value falls outside the standard range and to measure the control sample again to confirm that it falls within the qc range before assaying a patient sample.A review of the information provided by the customer showed that the column count was at 2814 injections, which exceeded the 2500 injection count recommended by (b)(4).Root cause for the reported event could not be determined.(b)(4).

Event Description

On (b)(6) 2017 the customer reported results were lower than expected.The customer stated that on (b)(6) 2017 service had decontaminated the instrument.Quality controls (qc) were within range at the time of service.On (b)(6) 2017 qc dropped in the morning; qc was in range even though level 1 had shifted down.The customer stated that patient results were reported out.The customer provided qc results from (b)(6) 2017, which were higher than the day after service was completed and closer to what was documented immediately after service.On (b)(6) 2017 the customer recalibrated the instrument after receiving calls from the clinics questioning results.Calibration equation and qc were within target range.The customer reran 4 patient samples, which had been originally run on (b)(6) 2017, respectively; chromatograms from before and after those dates were provided as well.Patient 1: on (b)(6) 2017: 5.2%, on (b)(6) 2017: 5.8%; patient 2: 10.25%, 11.1%; patient 3: 6.9%, 7.6; patient 4: 5.8, 6.5.A review of the chromatograms by the (b)(4) technical support specialist indicated that they were within acceptable criteria; good peak definition and baseline as well.The customer indicated that on (b)(6) 2017 a notice was sent out to physicians offering a repeat runs.On 12-apr-2017 the customer did not know whether any physicians requested to repeat runs.The customer recalibrated and calibration equation looked more normal; there was little difference in qc results or patient results between runs with the two calibration equations.No additional information was provided by the customer.

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a 13-month complaint history review and service history review for similar complaints was performed for the g8, serial number (b)(4), from (b)(6) 2016 through (b)(6) 2017.There were no other similar complaints identified during the searched period.The most probable cause of the reported event could not be determined.Corrected data: suspect medical device: expiration date was incorrectly provided; there is no expiration for this device.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: 6776500
• MDR Text Key: 82774453
• Report Number: 8031673-2017-00003
• 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: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2009
• 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: 03/27/2017
• Device Age: 10 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/27/2017
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1