MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number	TSH
Medical Device Problem Codes	Low Test Results (2458); Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer could not find a problem with the analyzer.He ran instrument checks and precision with good results.The customer performed qc that had results within specification.The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable low elecsys tsh assay result for one patient sample from cobas e 801 analytical unit serial number (b)(4).The initial result was 0.225 uiu/ml and was reported outside of the laboratory.Based on the result, the endocrinologist suggested lowering the patient's synthroid medication from 88 mcg to 77 mcg.The patient questioned the result as six months earlier the result was 3.26 uiu/ml and all previous results over the several years prior were consistent.The patient had not changed the dosage of medication or altered the way in which medicine was taken.The patient asked for repeat testing and a new sample was drawn on (b)(6) 2022 and tested on an unknown analyzer.The result was 1.66 uiu/ml and was believed to be correct as it was more in line with previous results.No changes were actually made to the patient's medications based on any of the results.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.The calibration and qc data were acceptable.The analyzer alarm trace contained sample clot detection, abnormal aspiration (sample probe), abnormal aspiration (sample probe a/b), and sample short errors.These are indicators of possible poor sample quality.

• Brand Name: ELECSYS TSH ASSAY
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13686340
• Report Number: 1823260-2022-00601
• Device Sequence Number: 13938878
• Product Code: JLW
• UDI-Device Identifier: 04015630899661
• UDI-Public: 04015630899661
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K961491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: TSH
• Device Catalogue Number: ASKU
• Device Lot Number: 57176501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNTHROID; VITAMIN D
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 67 KG