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

Catalog Number 09007784190

Device Problem High Test Results (2457)

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

Event Date 08/18/2023

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 323252630
• Report Number: 1823260-2023-02969
• Device Sequence Number: 1
• Product Code: CDX
• UDI-Device Identifier: 07613336171677
• UDI-Public: 07613336171677
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K961490
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09007784190
• Device Lot Number: 71166801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; IBUPROFEN; OMEPRAZOLE
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 104 KG