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

Catalog Number ASKU

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for three samples from the same patient tested for the elecsys tsh assay (tsh), elecsys ft3 iii (ft3), and the elecsys ft4 ii assay (ft4) on a cobas e 411 immunoassay analyzer (e411).This medwatch will apply to the ft4 assay.Please refer to the medwatch with (b)(6) for information concerning the tsh assay and refer to the medwatch with (b)(6) for information concerning the ft3 assay.The values highlighted in yellow are erroneous.The samples were initially tested for tsh and ft4 at the customer site on the e411 analyzer.The customer's e411 values for the (b)(6) 2017 sample were reported outside of the laboratory.It was asked, but it is not known if erroneous results were reported outside of the laboratory for the (b)(6) 2017 samples.The samples were repeated for tsh and ft4 on a lumipulse presto ii analyzer.Every other week, the customer tests tsh and ft4 on the e411 in parallel to a lumipulse presto ii analyzer at a branch laboratory.In order to fit the measurements from the lumipulse analyzer, the customer changes the settings on their e411 analyzer to multiply values by a coefficient.The following coefficients are applied in the e411 software: for tsh: result × 0.819, for ft4: result × 0.862 + 0.06.The samples dated (b)(6) 2017 were also provided for investigation where they were tested for tsh, ft4, and ft3 on a second e411 analyzer.No adverse events were alleged to have occurred with the patient.The e411 analyzer used at the customer site was serial number (b)(4).The e411 analyzer used for investigation was (b)(4).Ft4 reagent lot number 265631, with an expiration date of september 2018 was used on this analyzer.Calibration and quality controls run for investigation were ok.In reference to the mathematical differences of values generated with different assays from different vendors, different values may be generated due to the different antibodies used, the different assay setups, and differences in the standardization methodology/materials used.In reference to the difference in values from different vendors compared to their respective normal reference ranges, the normal reference ranges of assays from different vendors may be calculated using different calculation methodology and different patient cohorts are used.In this context, it also needs to be taken into account that differences in the normal reference ranges can occur, based upon age, gender and medication taken.Reduced tsh and ft4 values were generated for the first measurement of the (b)(4) 2017 sample on the e411 analyzer used for investigation.An analyzer specific issue or a sample specific issue such as a sample clot or foam/bubbles on the sample surface may have led to a lower amount of sample being pipetted.A general reagent issue can most likely be excluded.

Manufacturer Narrative

No erroneous results were reported outside of the laboratory for the (b)(6) 2017 and (b)(6) 2017 samples.

• Brand Name: ELECSYS FT4 II ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7053548
• MDR Text Key: 93570529
• Report Number: 1823260-2017-02736
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

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: ASKU
• Device Lot Number: ASKU
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 10/31/2017
• Supplement Dates FDA Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR