MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HTLV-I/II; HUMAN T-CELL LYMPHOTROPHIC VIRUS 1 & 2 (HTLV1 & HTLV2) ANTIBODY IVD, KIT

Catalog Number	09015272162
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The elecsys syphilis result was obtained on a cobas e 801 analytical unit with serial number (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys htlv-i/ii and elecsys syphilis results for 1 patient on a cobas e 801 analytical unit.The elecsys htlv-i/ii result was reactive.On (b)(6) 2026, the (western blot method) confirmatory htlv test result was "confirmed indeterminate".The elecsys syphilis result was reactive on (b)(6) 2026, the (captia-g method) confirmatory syphilis test result was "confirmed non-reactive".The sample was repeated because of the initially reactive results.This medwatch will apply to the elecsys htlv-i/ii assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the elecsys syphilis assay.

• Brand Name: ELECSYS HTLV-I/II
• Common Device Name: HUMAN T-CELL LYMPHOTROPHIC VIRUS 1 & 2 (HTLV1 & HTLV2) ANTIBODY IVD, KIT
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 25333412
• Report Number: 1823260-2026-02126
• Device Sequence Number: 9880923
• Product Code: QHM
• UDI-Device Identifier: 07613336183090
• UDI-Public: 07613336183090
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BL 125792/0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: 09015272162
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/29/2026
• 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 Sex: Unknown