MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-2000 ST

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

A field service engineering (fse) was at the customer's site to address reported event.Fse confirmed the complaint by reviewing the error logs and reproduced the out of range reagents qc.While troubleshooting, fse found bf2 probe alignment screw loose, which would have affected proper processing of all the reagents.Fse resolved complaint by aligning bf2 probe and tightened screw.Fse validated the analyzer by successfully performed quality control run without error and within acceptable range.No further action required by field service.The aia-2000 analyzer is functioning as expected.(b)(4).The aia-2000 operator's manual under appendix 4: error messages states the following: b/f probe 2 purge failure cause : the overflow sensor failed to detect liquid even after the washer was purged.Solution : air may be trapped in the washer tubing.Purge any remaining air by performing the priming operation and check for the presence of air in the washer tubing.If retry fails, contact tosoh service center or local representatives.The st aia-pack prolactin (prl) and follicle stimulating hormone (fsh) analyte application manual states the following: evaluation of results quality control in order to monitor and evaluate the precision of the analytical performance, it is recommended that commercially available control samples be assayed daily.The minimum recommendations for the frequency of running internal control material are: after calibration, two levels of controls are run in order to accept the calibration curve.The two levels of controls are also repeated after calibration when certain service procedures are performed (e.G.Temperature adjustment, sampling mechanism changes, maintenance of the wash probe or detector lamp adjustment or change).After daily maintenance, at least two levels of the control should be run in order to verify the overall performance of the tosoh aia system analyzers.If one or more control sample value(s) is out of the acceptable range, it will be necessary to investigate the validity of the calibration curve before reporting patient results.Standard laboratory procedures should be followed in accordance with the regulatory agency under which the laboratory operates.The most probable cause of the reported event is due to bf2 probe out of alignment.

Event Description

A customer reported getting error message "2240 bf probe 2 purge failure" and out of range quality control (qc) results for several reagents including prl and fsh on the aia-2000 analyzer.The customer states that, when the wash reagent gets low, the bf probes are checked and tips changed but the error persists.Error clears when the reagent is replaced, but out of range qc persists.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient samples for prolactin (prl) and follicle stimulating hormone (fsh).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: AIA-2000
• Type of Device: FLUOROMETER, FOR CLINICAL USE
• Manufacturer (Section D): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer (Section G): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer Contact: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 14230822
• MDR Text Key: 290944057
• Report Number: 3004529019-2022-00088
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 04560189284616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000 ST
• Device Catalogue Number: 022100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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