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

Catalog Number	08443432190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys tsh and elecsys ft4 iv results from one patient sample tested on the cobas e 801 module.This mdr is for the tsh assay.Please refer to the medwatch with a1.Patient identifier pt-(b)(6) for the ft4 iv assay.The initial results were reported to the doctor.On 04-sep-2023, the initial tsh result was 0.021 iu/ml.On 07-sep-2023, the repeat result was 2.42 iu/ml.
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 module is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
D4 lot no, d4 expiration date, d4 catalog no, d4 udi and g4 pma / 510k (premarket numbers) were updated.The investigation reviewed the calibrations; the results were within specifications.The investigation reviewed the qc data; the qc results were within specifications.A general reagent issue can most likely be excluded based on the calibration and qc results.The investigation determined the event was consistent with a preanalytic issue (pipetting of an insufficient amount of sample or foam/air bubbles on the sample surface) at the customer site.Preanalytics are within the customer's responsibility.There was no indication of a device malfunction.

• Brand Name: ELECSYS TSH
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18028334
• Report Number: 1823260-2023-03454
• Device Sequence Number: 6962247
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• PMA/510(K) Number: K961491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2023

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: 03/31/2024
• Device Catalogue Number: 08443432190
• Device Lot Number: 67468901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown