MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4; RADIOIMMUNOASSAY, TOTAL THYROXINE

Catalog Number	09007784190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e801 immunoassay analyzer serial number was (b)(6).The customer uses a 3rd party qc.Qc was performed on the morning of the event and was acceptable.On (b)(6)2023 a new reagent pack was loaded.The field service engineer (fse) found bubbles in the reagent.The customer removed the bubbles.The fse verified the reagent and it was performing within specifications.Investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant resyults for 1 patient's serum sample tested with elecsys thyroxine (t4) on a cobas e801 immunoassay analyzer.Initial result: 18 g/dl.This result was considered high and it did not match the patient's clinical picture.Repeat result: 7.66 g/dl.The questionable result was reported outside the laboratory but the customer noticed and deleted it from the patient's record before the physician accessed the result.The repeat result was deemed to be correct.
Additional Manufacturer Narrative
The last calibration was performed on (b)(6) 2023 and it was acceptable.The alarm trace noted multiple reagent short alarms and sample short alarms on the date of the event near the time the sample was processed.No further issues were reported after the service visit.

• Brand Name: ELECSYS T4
• Common Device Name: RADIOIMMUNOASSAY, TOTAL 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
• MDR Report Key: 17735352
• Report Number: 1823260-2023-02969
• Device Sequence Number: 12221983
• Product Code: CDX
• UDI-Device Identifier: 07613336171677
• UDI-Public: 07613336171677
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K961490
• 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,Followup
• Report Date (Section B): 09/29/2023

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: 06/30/2024
• Device Catalogue Number: 09007784190
• Device Lot Number: 71166801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN; IBUPROFEN; OMEPRAZOLE
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 104 KG