MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TSH ELECSYS E2G 300 V2; THYROID-STIMULATING HORMONE ASSAY

Catalog Number	08443432190
Medical Device Problem Codes	Cross Reactivity (1137); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).A sample from the patient was requested for investigation.
Event or Problem Description
There was an allegation of questionable tsh results from the cobas e 801 analytical unit.On (b)(6) 2023, the result from an abbott i2000sr was 1.0957 uiu/ml.On (b)(6) 2023, the result from the cobas e801 was 33.4 uiu/ml.On (b)(6) 2023, the result from a siemens centaur xp was 1.441 uiu/ml.The sample was diluted sample using saline and low tsh serum and the results were 1.524 and 1.46 uiu/ml.On (b)(6) 2023, the result from the coabs e801 was 33.4 uiu/ml.The sample from (b)(6) 2023 was diluted using low tsh serum and the results were: undiluted: 35 uiu/ml.1:1 dilution: 35.1 uiu/ml.1:2 dilution: 60.2 uiu/ml.1:4 dilution: 89.6 uiu/ml.1:8 dilution: 117.6 uiu/ml.The result using 25% peg 1:1 was 1.54 uiu/ml.Recovery 8.8%.The sample from (b)(6) 2023 was diluted using low tsh serum and the results were: undiluted: 34.3 uiu/ml.1:1 dilution: 33.5 uiu/ml.1:2 dilution: 56.2 uiu/ml.1:4 dilution: 82 uiu/ml.1:8 dilution: 116.8 uiu/ml.The result using 25% peg 1:1 was 1.32 uiu/ml.Recovery 7.7%.
Additional Manufacturer Narrative
Medwatch field d4 expiration date and d4 catalog no were updated.
Additional Manufacturer Narrative
A sample from the patient was received for investigation and the customer's result was confirmed.Upon further investigation, a fab2 interfering factor was found in the sample which affected the elecsys tsh assay.Per product labeling: in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.A general product problem could be excluded.

• Brand Name: TSH ELECSYS E2G 300 V2
• Common Device Name: THYROID-STIMULATING HORMONE ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18358814
• Report Number: 1823260-2023-04120
• Device Sequence Number: 8089321
• Product Code: JLW
• UDI-Device Identifier: 07613336193693
• UDI-Public: 07613336193693
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K190773
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2024

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: 11/30/2024
• Device Catalogue Number: 08443432190
• Device Lot Number: 733296
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 01/22/2024; 02/09/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 02/02/2024; 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian