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

Catalog Number	08443432214
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable tsh elecsys e2g 300 v2 and elecsys ft3 results for 1 patient sample on a cobas 8000 core unit.Please refer to the highlighted section of attachment (b)(6) for patient results.The customer also performed a tsh dilution test on the sample.A dilution of (x2) produced a conversion result of 3.080 iu/ml and a recovery result of 134%.A dilution of (x5) produced a conversion result of 3.920 iu/ml and a recovery result of 170%.A dilution of (x10) produced a conversion result of 4.440 iu/ml and a recovery result of 193%.This medwatch will apply to the tsh assay.Please refer to the medwatch with a1.Patient identifier pt (b)(6) for information related to the ft3 assay.
Additional Manufacturer Narrative
The sample was returned for investigation.An interfering factor against the streptavidin component of the reagents was detected in the sample, causing a falsely elevated value of the ft3iii assay and the different values of the tsh assay.Product labeling states: "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.".

• 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: 18857013
• Report Number: 1823260-2024-00692
• Device Sequence Number: 8295049
• Product Code: JLW
• UDI-Device Identifier: 07613336193693
• UDI-Public: 07613336193693
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 05/13/2024

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 Catalogue Number: 08443432214
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 05/13/2024
• 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: 43 YR
• Patient Sex: Female