MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-14 for TOSOH HLC-723G8 ANALYZER G8 021560 manufactured by Tosoh Corporation.
[138252253]
(b)(4) device evaluation by manufacturer: a field service engineer (fse) was dispatched to the customer's site to address the reported event. Fse confirmed complaint by observing the flow rate set to 1. 24. Fse replaced the check valve uptake. The customer successfully completed quality control (qc) run to validate instrument. No further action required by field service. The g8 instrument is functioning as expected. The check valve uptake was returned to tosoh instrument service center for investigation. Functional testing confirmed the reported fast retention time was due to partially occluded check valve uptake. A 13-month complaint history review and service history review for similar complaints was performed for the g8, serial number (b)(4) through aware date. There were no other similar complaints identified during the searched period. The g8 operator's manual under chapter 1, introduction and applications, states the following: the time from injection of the sample to the time the specific peak elutes off the column is called retention time. The tosoh automated glycohemoglobin analyzer hlc-723g8 software has been written so that each of the expected fractions has a window of acceptable retention times. If the designated peak falls within the expected window, the chromatogram peaks will be properly identified. When a peak elutes at a retention time not within a specified window, an unknown peak (p00) results. If more than one peak elutes at times not specified by the software windows, each is given a sequential p0x title. In order to keep the peaks within their appropriate windows, it may be necessary to change how fast or slow the buffers are moving through the system by changing the pump flow rate. The g8 variant analysis mode training manual under lesson 8 - troubleshooting, states the following: adjusting the flow rate - how and why: on the tosoh automated glycohemoglobin analyzer hlc-723g8; variant analysis mode it may be necessary to adjust the flow rate because either unidentifiable peaks appear on all the chromatograms or the average retention time for various peaks has changed significantly. The flow rate is changed by changing the flow factor in the instrument. The flow factor is generally 1. 00 ml/min. The flow factor should only be adjusted +/- 0. 05 of the default factory setting. The most probable cause of the fast retention time was due to the failure of the check valve uptake.
Patient Sequence No: 1, Text Type: N, H10
[138252254]
A customer reported seeing fast sa1c retention time (rt) (acceptable range is 0. 57 to 0. 61 minutes) on patient samples with the g8 instrument. The technical support specialist (tss) advised the customer to adjust the flow factor from 1. 18 ml/min to 1. 21 ml/min in order to adjust the retention time to acceptable range of 0. 57 to 0. 61 minutes. Customer was also advised to power off and on instrument, then prime instrument with five samples run, calibrate and run quality controls (qc), then run patient samples. Customer followed up and stated, rt is still high on qc and p00 flag occurred. Tss advised the customer to adjust the flow factor again from 1. 21 ml/min to 1. 23 ml/min, then calibrate and run qc. The run completed with still fast rt at 0. 62. Customer was advised to adjust the flow rate again, and the sa1c rt was 0. 59 which is within acceptable range. The sa1c rt remained in range for several days, but customer later reported the sa1c rt is still drifting. 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 was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031673-2019-00024 |
| MDR Report Key | 8341370 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-14 |
| Date of Report | 2019-02-14 |
| Date of Event | 2018-12-27 |
| Date Facility Aware | 2018-12-27 |
| Report Date | 2019-02-14 |
| Date Reported to FDA | 2019-02-14 |
| Date Reported to Mfgr | 2019-02-14 |
| Date Mfgr Received | 2018-12-27 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2019-02-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DORIA ESQUIVEL |
| Manufacturer Street | 6000 SHORELINE COURT SUITE 101 |
| Manufacturer City | SOUTH SAN FRANCISCO CA 94080 |
| Manufacturer Country | US |
| Manufacturer Postal | 94080 |
| Manufacturer Phone | 6509368123 |
| Manufacturer G1 | TOSOH CORPORATION (MANUFACTURER) |
| Manufacturer Street | SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA |
| Manufacturer City | MINATO-KU, TOKYO, JAPAN 1058623 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 1058623 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOSOH HLC-723G8 ANALYZER G8 |
| Generic Name | G8 |
| Product Code | LCP |
| Date Received | 2019-02-14 |
| Returned To Mfg | 2019-01-22 |
| Model Number | G8 |
| Catalog Number | 021560 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOSOH CORPORATION |
| Manufacturer Address | SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA MINATO-KU, TOKYO, JAPAN 1058623 JA 1058623 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-14 |