MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ASKU; RADIOIMMUNOASSAY, FREE THYROXINE

Model Number ASKU

Device Problem High Test Results (2457)

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

Event Date 10/17/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

There was a complaint of questionable elecsys tsh and ft4 results for 1 patient tested with a cobas e801 module serial number (b)(4).The questionable tsh results were not reported outside the laboratory.It is unknown if the questionable ft4 results were reported outside of the laboratory.The patient¿s initial tsh result on the client¿s e801 was 13.2.The patient¿s initial ft4 result on the client¿s e801 was 21.7.The patient¿s sample was repeated at a second laboratory on (b)(6) 2021 with an unspecified competitor method.The patient¿s repeated tsh result was 4.045 iu/ml.The patient¿s repeated ft4 result was 15.3 pmol/l.The units of measurement were requested but not provided for all assays.The specific ft4 reagent used was requested but not provided.This medwatch is for the ft4.Refer to the medwatch with patient identifier (b)(6) for the elecsys tsh.

Manufacturer Narrative

The customer stated an interfering factor was found and pre-treatment was done and the sample was reanalyzed.Further information was not provided.The sample was requested for investigation but was not provided.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ASKU
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13002261
• MDR Text Key: 288495669
• Report Number: 1823260-2021-03701
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: QA
• PMA/PMN Number: ASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

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 Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 02/15/2022
• 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