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

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer stated that they received erroneous results for one patient sample tested with the elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 ii assay an a cobas 6000 e 601 module.The erroneous results were reported outside of the laboratory and the physician requested an investigation of the sample.The sample was provided for investigation where it was tested for tsh, ft3, and ft4 ii on a cobas 8000 e 602 module on (b)(6) 2018.The sample was repeated on a centaur analyzer and an architect analyzer.This medwatch will apply to the ft4 ii assay.Please refer to the medwatches with the following patient identifiers for information related to the remaining assays: (b)(6) = tsh.(b)(6) = ft3.No adverse events were alleged to have occurred with the patient.The customer's e 601 analyzer serial number is (b)(4).The e 602 analyzer used for investigation is (b)(4).Ft4 ii reagent lot number 288197, with an expiration date of may 2019 was used on this analyzer.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.All values generated with the analyzers from roche diagnostics are marginally above/below the upper level of the normal reference range of the assay.The values generated with the analyzers from siemens and abbott are slightly below the upper level of the normal reference ranges of the respective assays.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7918619
• MDR Text Key: 122046226
• Report Number: 1823260-2018-03339
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 04015630930920
• UDI-Public: 4015630930920
• Combination Product (y/n): N
• PMA/PMN Number: K961489
• 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: 10/29/2018

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: 06437281190
• Device Lot Number: 315901
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 09/10/2018
• Supplement Dates FDA Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1