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

Catalog Number	06437281160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that they have one patient with a history of samples containing a suspected interfering substance when tested with the elecsys tsh assay and the elecsys ft4 ii assay on a cobas 8000 e 602 module.The customer states that they have ruled out all known interfering substances listed in product labeling for both assays.The patient also did not take any biotin supplements.The customer provided data for one sample from the patient with erroneous tsh and ft4 results when comparing to results measured with competitor systems.The erroneous results were not reported outside of the laboratory.The results from the competitor systems were reported outside of the laboratory.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay.The sample resulted with a tsh value of 0.005 miu/l when tested on the e 602 analyzer.The sample was repeated on a beckman dxi, resulting with a tsh value of 0.10 miu/l (beckman dxi tsh reference range = 0.3 - 4.3 miu/l for patients >/= to 1 year of age).The sample resulted with a ft4 value of 2.61 ng/dl when tested on the e 602 analyzer.The sample was repeated on a siemens centaur xpt analyzer, resulting with a ft4 value of 1.44 ng/dl (centaur reference range = 0.8 - 1.8 ng/dl).The patient was not adversely affected.The e 602 analyzer serial number is (b)(4).The customer declined a service visit stating that the issue was patient/sample specific.
Additional Manufacturer Narrative
The customer provided a sample for investigation.The results generated at the customer site were confirmed.The investigation found an interfering factor against a component of the assay in the sample.The package insert states in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.

• Brand Name: ELECSYS FT4 II ASSAY
• Common Device Name: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7877666
• Report Number: 1823260-2018-03145
• Device Sequence Number: 16189611
• Product Code: CEC
• UDI-Device Identifier: 04015630934232
• UDI-Public: 04015630934232
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 06437281160
• Device Lot Number: 30324101
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN; CALCIUM CARBONATE/VITAMIN D3; HYDROCORTISONE; KETOCONAZOLE; LEVOTHYROXINE; LISINOPRIL; METFORMIN; METOPROLOL TARTRATE; MIRALAX; NYSTATIN POWDER; OMEPRAZOLE; PHENYLEPHRINE/WITCH HAZEL GEL; SIMVASTATIN; SODIUM CHLORIDE-SODIUM BICARBONATE KIT, NASAL; VENLAFAXINE
• Patient Age: 75 YR
• Patient Weight: 107