MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 IV; FREE THYROXINE

Model Number FT4 IV

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

1.Describe the event: there was an allegation of questionable high elecsys ft4 iv results for 2 patient samples.2.Patient age range: 1 patient: 86 years, other: asku 3.Patient weight range: asku 4.Patient sex breakdown: 1 f, 1 asku 5.Patient race breakdown: asku 6.Patient ethnicity breakdown: asku.

Manufacturer Narrative

1.Summary of investigation results: the investigation is ongoing.2.Summary of follow up/corrective actions taken: the investigation is ongoing.3.Device returned to manufacturer? no 4.Device labeled "for single use?"? no 5.Device reprocessed and reused? no.

• Brand Name: ELECSYS FT4 IV
• Type of Device: FREE THYROXINE
• 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 46250-0457 ; 3175216208
• MDR Report Key: 19202595
• MDR Text Key: 341598053
• Report Number: 1823260-2024-01304
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 07613336172780
• UDI-Public: 07613336172780
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2024

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
• Device Model Number: FT4 IV
• Device Catalogue Number: 09043284190
• Device Lot Number: 74937201
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1