MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-07 for AIA-2000 022100 manufactured by Tosoh Corporation.
[182473640]
Fse arrived at the site to address the reported event. Fse confirmed the issue by reviewing the error log and reproduced the error by running a b12 calibration. While reviewing the error log, fse noted that several other different errors had occurred over the past few days indicating a type of computer or processing error. Fse replaced the main cpu board, reloaded the version 2. 09 software, verified power supply voltages and hybrid arm z & y-axis alignments, and then cleaned the main incubator, p/d table, and both hybrid and main sample nozzles as routine maintenance. Fse also verified the computer power settings, wi-fi, and firewall settings. The customer was subsequently able to run b12 calibration and all controls without error. When fse followed up with the customer again, they reported receiving the "2110 clogging detected during pretreatment reagent suction by hybrid arm" error. Fse confirmed the error by reviewing the error log but was unable to reproduce the error due to time constraints. Further inspection of the analyzer revealed that the clot detection adjustment was out of specification (offset=218 gain=946). Fse calibrated the hybrid arm clot detection to specification (offset=242 gain=889) and verified the sorter tip alignment. No further issues were noted. No further action was required by field service. A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 07jan2019 to aware date (b)(6) 2020. There were no similar complaints identified during this search period. The a1a-2000 operator's manual under appendix 4- error messages was reviewed. 4253 hybrid arm z-axis home overrun the a1a-2000 operator's manual indicates that the 4253 hybrid arm z-axis home overrun occurs when the home sensor activates improperly after movement of the hybrid arm z-axis. If the retry fails, the measurement result will be flagged (mf flag). The operator is instructed to contact tosoh service center or local representatives. 2256 no rack at sample loader transfer-in-position the a1a-2000 operator's manual indicates that the 2256 no rack at sample loader transfer-in-position occurs when the x1 start-point rack detection sensor and the x3 start-point rack detection sensor fails t detect a rack even after the transfer-in (y1, y3) belts are engaged. The operator is instructed to place the sample rack in the loader transfer-in position. If the retry fails, contact tosoh service center or local representatives. 2110 clogging detected during pretreatment reagent suction by hybrid arm the a1a-2000 operator's manual indicates that the 2110 clogging detected during pretreatment reagent suction by hybrid arm occurs when clogging is detected after pretreatment reagent suction. The measurement result will be flagged (es flag). The operator is instructed to contact tosoh service center or local representatives. The most probable cause of the reported event was due to failure of the main cpu board and readjustment required for the hybrid arm clot detection.
Patient Sequence No: 1, Text Type: N, H10
[182473641]
The customer reported receiving the "4253 hybrid arm z-axis home overrun" and "2256 no rack at sample loader transfer-in-position" errors on their aia-2000st analyzer. The customer rebooted but the errors persisted. The analyzer was down. A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for intact parathyroid hormone (ipth). 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 | 8031673-2020-00053 |
| MDR Report Key | 9803579 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-07 |
| Date of Report | 2020-03-07 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2017-02-01 |
| Date Added to Maude | 2020-03-07 |
| 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. BERNADETTE OCONNELL |
| Manufacturer Street | SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA |
| Manufacturer City | MINATO-KU, TOKYO 1058623 |
| Manufacturer Country | JA |
| Manufacturer Postal | 1058623 |
| Manufacturer G1 | TOSOH CORPORATION |
| Manufacturer Street | SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA |
| Manufacturer City | MINATO-KU, 1058623 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 1058623 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIA-2000 |
| Generic Name | AIA-2000 |
| Product Code | KHO |
| Date Received | 2020-03-07 |
| Model Number | AIA-2000 |
| Catalog Number | 022100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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, 1058623 JA 1058623 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-07 |