MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FSH; RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE

Catalog Number	08932352190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys follicle stimulating hormone (fsh) assay on a cobas 6000 core unit.Initial result: 7.52 miu/ml.The physician questioned the initial result as it did not match the patient's previous results.Repeat result: 19.10 miu/ml.The repeat result was deemed to be correct.
Additional Manufacturer Narrative
The fsh reagent expiration date was not provided.The cobas 6000 core unit serial number was (b)(6).The qc was within the assigned ranges on the day of the event.The investigation is ongoing.
Additional Manufacturer Narrative
Section d4 was updated.Correction: the cobas 6000 core unit e601 module serial number was (b)(6) instead of (b)(6).The calibration for lot number 850527 was within expectation.The chart showed that the calibration before that had some issues.A general reagent or analyzer problem can be excluded because the qc prior to the event was within ranges.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FSH
• Common Device Name: RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE
• 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: 22086907
• Report Number: 1823260-2025-01602
• Device Sequence Number: 7866509
• Product Code: CGJ
• UDI-Device Identifier: 07613336170373
• UDI-Public: 07613336170373
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• 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): 06/27/2025

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: 07/31/2025
• Device Catalogue Number: 08932352190
• Device Lot Number: 766224
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/27/2025
• 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