MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 II ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number 06437281160

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)# (b)(4).

Event Description

The customer complained that the elecsys ft4 ii assay (ft4 ii) results for 4 patients were not matching the patient's clinical pictures when tested on a cobas 6000 e 601 module.Please refer to the attachment for relevant patient data.The questionable results were released outside of the laboratory.There was no adverse event.The customer deemed the high performance liquid chromatography-tandem mass spectrometry (hplc¿ms/ms) result for patient id 1321448 to be correct.The customer's cobas e601 serial number was (b)(4).The customer stated that there have not been any issues with calibrations and that qc results have been acceptable.The customer had recently had preventative maintenance performed on their cobas e601 on (b)(6) 2018.The investigation is currently ongoing.

Manufacturer Narrative

Further information about the patient with an identification number of (b)(6) was provided.

Manufacturer Narrative

The customer believed the issue was due to a cross-reactivity of the reagent.The customer stated that the endocrinologists were not used to the roche ft4 ii reference ranges compared to the beckman analyzer.The customer stated that there have been no issues with calibrations or qc.A field engineering specialist performed targeted maintenance.He replaced the syringe seals, o-rings, and the pinch valve tubing.He cleaned and lubricated the mechanisms.The customer ran calibration and qc with acceptable results.The investigation was unable to find a definitive root cause.

• Brand Name: ELECSYS FT4 II ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7641241
• MDR Text Key: 112854603
• Report Number: 1823260-2018-02069
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2018

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 Catalogue Number: 06437281160
• Device Lot Number: 303241
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 06/08/2018; 06/08/2018
• Supplement Dates FDA Received: 07/12/2018; 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE 75 MG/DAY; PRENATAL CAPSULES
• Patient Age: 35 YR
• Patient Weight: 103