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

Model Number FT4 G3

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Medwatch field udi number = (b)(4).

Event Description

The initial reporter stated they received questionable results for two patient samples tested with the elecsys ft4 iii assay on a cobas 8000 e 801 module.No incorrect results were reported outside of the laboratory.The first sample initially resulted in a ft4 value of 0.72 ng/dl.The sample was then poured into a non-specific antibody capture tube and tested on the analyzer in a sample cup, resulting in a value of 1.10 ng/dl on (b)(6) 2021.The second sample initially resulted in a ft4 value of 0.82 ng/dl on (b)(6) 2021.The sample was then poured into a non-specific antibody capture tube and tested on the analyzer in a sample cup, resulting in a value of 1.10 ng/dl on (b)(6) 2021.The patient values were expected to be "between normal and high".The serial number of the e 801 analyzer is (b)(4).

Manufacturer Narrative

The initial ft4 value for sample 1 was 0.718 ng/dl and the repeat value was 1.01 ng/dl.The initial ft4 value for sample 2 was 0.818 ng/dl.The samples resulted in the following additional test data: sample 1: t4: 5.71 ¿g/dl t3: 0.556 ng/ml ft3 iii: 0.718 ng/dl cort: 3.71 ug/dl fsh: 0.365 miu/ml lh: 0.300 miu/ml prl: 10.1 ng/ml tsh: 0.0539 uiu/ml sample 2: t4: 3.84 ¿g/dl t3: 0.587 ng/ml ft3 iii: 1.84 pg/ml tsh: 0.174 uiu/ml calibration and controls were acceptable.No patient sample material was available for investigation.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11507810
• MDR Text Key: 268500478
• Report Number: 1823260-2021-00841
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

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: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: 483198
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1