MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR; ANTI-TSHR IMMUNOASSAY

Catalog Number 07026951190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of qc and calibration issues when testing elecsys anti-tshr (anti-tshr) on a cobas e801 module.The customer installed the anti-tshr reagent on (b)(6) 2018.There were no qc issues between (b)(6) 2018 and (b)(6) 2018.The customer began to run routine patient samples on (b)(6) 2018.The customer received qc data flags on (b)(6) 2018 on channel 2 of the instrument and started to only use channel 1 for patient results.On (b)(6) 2018 the customer received qc data flags on channel 1 and not channel 2.The customer attempted to re-calibrate; however, the calibration failed.Since there were no qc issues with channel 2, the customer used channel 2 for patient results.The customer contacted the sales representative who advised the customer to repeat the patient samples on a different e801 module.Upon repeat testing, discrepant high anti-tshr results were identified for 8 patient samples.The initial high results had been reported outside of the laboratory.There was no allegation that an adverse event occurred.The e801 module serial number was (b)(4).The field service engineer (fse) visited the customer site where no instrument issues were identified.The anti-tshr reagent has been used up and is no longer available.The fse performed reproducibility tests with the newly prepared reagents on both channel 1 and channel 2 of the instrument and there were no issues.During a review of the alarm trace data, no instrument issues were identified.Instrument check results were within specification.Based on the data available, the incorrect results were generated using an old calibration from (b)(6) 2018.Daily calibration is recommended for anti-tshr.If results using an incorrect calibration are compared to results from another system with correctly calibrated reagent, differences are expected.Investigations are ongoing.

Manufacturer Narrative

Initial calibration of the reagent was successful.The recalibration of the reagent failed.Two qc results above the measuring range were observed.The instrument check data and the alarm trace show no issues.A general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR
• Type of Device: ANTI-TSHR IMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8226462
• MDR Text Key: 132414278
• Report Number: 1823260-2019-00092
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• PMA/PMN Number: K080092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 07026951190
• Device Lot Number: 322386
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1