MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TSH ELECSYS COBAS E 200 V2; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number	TSH
Medical Device Problem Codes	High Test Results (2457); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer performed comparison testing for prolactin and tsh and recovered acceptable results.He completed precision and performance testing with acceptable results.He performed calibration and qc with passing results.The customer sent 8 samples to a different laboratory for comparison testing.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys tsh assay results for one patient tested on a cobas 6000 e 601 module serial number (b)(4).Prior to patient testing, the customer's tsh qc was acceptable.The patient had two samples collected at the same time.One sample was tested on the cobas 6000 e 601 module and the other sample was sent to a different laboratory and was tested with an unknown laboratory methodology.The patient's elecsys tsh result was 7.06 uiu/ml.The patient's tsh result at a different laboratory was 4.39 miu/l.The customer was unsure which result was correct.
Additional Manufacturer Narrative
The customer confirmed the samples sent to a different laboratory for comparison testing were acceptable.The investigation found the last calibration was performed on 18-jul-2021 and was acceptable.The alarm trace does not contain a conspicuous event.As the customer was unable to provide further information, a definite root cause analysis is not possible.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: TSH ELECSYS COBAS E 200 V2
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12306087
• Report Number: 1823260-2021-02334
• Device Sequence Number: 14373082
• Product Code: JLW
• UDI-Device Identifier: 07613336157626
• UDI-Public: 07613336157626
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K961491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: 04/30/2022
• Device Model Number: TSH
• Device Catalogue Number: 08429324160
• Device Lot Number: 51256600
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR