AIA-2000 022100

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number8031673-2020-00053
MDR Report Key9803579
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-07
Date of Report2020-03-07
Date of Event2020-02-07
Date Mfgr Received2020-02-07
Device Manufacturer Date2017-02-01
Date Added to Maude2020-03-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. BERNADETTE OCONNELL
Manufacturer StreetSHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA
Manufacturer CityMINATO-KU, TOKYO 1058623
Manufacturer CountryJA
Manufacturer Postal1058623
Manufacturer G1TOSOH CORPORATION
Manufacturer StreetSHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA
Manufacturer CityMINATO-KU, 1058623
Manufacturer CountryJA
Manufacturer Postal Code1058623
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAIA-2000
Generic NameAIA-2000
Product CodeKHO
Date Received2020-03-07
Model NumberAIA-2000
Catalog Number022100
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTOSOH CORPORATION
Manufacturer AddressSHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA MINATO-KU, 1058623 JA 1058623


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-07

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