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

Model Number FT4

Device Problem High Test Results (2457)

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

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Udi number = (b)(4).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys ft3 iii and the elecsys ft4 assay on a cobas 8000 e 801 module.It is not known which specific ft4 reagent was used by the customer.The results from the e 801 analyzer were reported outside of the laboratory to the doctor.This medwatch will apply to the ft4 assay.Please refer to the medwatch.Patient identifier (b)(6) for information related to the ft3 assay.The sample was tested twice on the e 801 analyzer, resulting in ft3 values of 9.79 pg/ml and 9.71 pg/ml (reference range = 2.50 - 4.30 pg/ml).The sample was repeated on an abbott system, resulting in a ft3 value of 2.50 pg/ml (reference range = 1.88 - 3.18 pg/ml).The sample was tested twice on the e 801 analyzer, resulting in ft4 values of 2.75 ng/dl and 2.69 ng/dl (reference range = 0.93 - 1.70 ng/dl).The sample was repeated on an abbott system, resulting in a ft4 value of 1.35 ng/dl (reference range = 0.70 - 1.48 ng/dl).The serial number of the customer's e 801 analyzer is (b)(4).

Manufacturer Narrative

The patient was taking the following medications on (b)(6) 2020: vitamin d2 capsule (calciferol), alprazolam tablet (xanax), chalktab (calcium carbonate), madiplot tablet (manidipine), prenolol tablet (atenolol), prolia injection (denosumab), livalo tablet (pitavastatin), and ezetrol tablet (ezetimibe).The patient was taking the following medications on (b)(6) 2021: salazopyrin (sulfasalazine), bamolin tablet (paracetamol + "orphenadrin"), methotrexate tablet, folic acid tablet, vitamin b complex tablet, multivitamin tablet.The patient was taking the following medications on (b)(6) 2021: bisoprolol tablet, enalapril tablet (anapril), furosemide tablet (furetic/impugan, lasix), orfarin tablets (warfarin).Samples from the patient were provided for investigation and it was determined they contained an interfering factor against a component of the ft4 assay, however, the exact identity of the interfering substance cannot be identified.Medwatch field d10.Has been updated.

• Brand Name: ELECSYS FT4 ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11673018
• MDR Text Key: 249668545
• Report Number: 1823260-2021-01154
• 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: 07/19/2021

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
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 03/25/2021
• Supplement Dates FDA Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALPRAZOLAM TABLET (XANAX); BAMOLIN TABLET (PARACETAMOL + "ORPHENADRIN"); BISOPROLOL TABLET; CHALKTAB (CALCIUM CARBONATE); ENALAPRIL TABLET (ANAPRIL); EZETROL TABLET (EZETIMIBE); FOLIC ACID TABLET; FUROSEMIDE TABLET (FURETIC/IMPUGAN, LASIX); LIVALO TABLET (PITAVASTATIN); MADIPLOT TABLET (MANIDIPINE); METHOTREXATE TABLET; MULTIVITAMIN TABLET; ORFARIN TABLETS (WARFARIN); PRENOLOL TABLET (ATENOLOL); PROLIA INJECTION (DENOSUMAB); SALAZOPYRIN (SULFASALAZINE); VITAMIN B COMPLEX TABLET; VITAMIN D2 CAPSULE (CALCIFEROL)
• Patient Age: 74 YR