MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number TSH

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

The customer's qc was acceptable.The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys ft4 ii assay, elecsys t4 assay, and elecsys tsh assay results for one patient tested on a cobas 8000 e 801 module.The patient¿s initial results were reported outside the laboratory.The patient¿s physician questioned the initial results and the customer performed further testing for confirmation.The customer performed additional testing on the same e 801 module, a beckman coulter dxi 800 analyzer, and a siemens centaur analyzer.The physician determined the beckman coulter results to be correct.Tsh reagent lot number was 45429600 with an expiration date requested but not provided.T4 reagent lot number was 44937600 with an expiration date requested but not provided.Ft4 reagent lot number was 45434500 with an expiration date requested but not provided.

Manufacturer Narrative

The customer confirmed a biotin interference was ruled out.The investigation verified the customer's calibration data was acceptable.The patient's sample was requested for an investigation due to a suspected interference, but the sample was not available.The investigation stated heterophilic blocking tube (hbt) testing was not a validated recommendation for tsh, ft4, and t4.For tsh dilution, product labeling states "samples with tsh concentrations above the measuring range can be diluted with diluent multiassay.The recommended dilution is 1:10 (either automatically by the analyzer or manually)." the investigation did not identify a product problem.The cause of the event could not be determined.Updated medwatch fields: d1, d2, d4, g1, g4.The following fields are to be filled in as follows in relation to the ft4 reagent: d1 - brand name: elecsys ft4 ii assay, d2 - common device name: radioimmunoassay, free thyroxine, d2b - product code: cec, d4 - model number: ft4 g2, d4 - catalog no: 07027397190, d4 - lot no: 45434500, d4 - expiration date 30-apr-2021, d4 unique identifier (udi) #: (b)(4), g4 - pma/510(k) #: k131244.The following fields are to be filled in as follows in relation to the t4 reagent: d1 - brand name: elecsys t4 assay, d2 - common device name: radioimmunoassay, total thyroxine, d2b - product code: cdx, d4 - model number: na, d4 - catalog no: 07027885190, d4 - lot no: 44937600, d4 - expiration date 30-apr-2021, d4 unique identifier (udi) #: (b)(4), g4 - pma/510(k) #: k961490.

• Brand Name: ELECSYS TSH ASSAY
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10808766
• MDR Text Key: 215313619
• Report Number: 1823260-2020-02816
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• PMA/PMN Number: K961491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: TSH
• Device Catalogue Number: 07028091190
• Device Lot Number: 45429601
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR