MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TSH ELECSYS E2G 300 V2; THYROID-STIMULATING HORMONE ASSAY

Catalog Number	08443432214
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit is (b)(6).The serial number of the investigation laboratory's cobas e 801 module is (b)(6) the tsh v2 reagent lot number used at the investigation site's e 801 was 714216 with an expiration date of 31-jul-2024.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys tsh v2 (tsh v2) results from one patient sample tested on the customer's cobas e 801 analytical unit and the investigation laboratory's cobas e 801 module.The reporter stated that they performed a polyethylene glycol (peg) addition test but the recovery rate was low prompting them to send the patient sample to an investigation laboratory.The investigation laboratory also sent the patient sample to an outsourced laboratory that uses an abbott architect.Please refer to the attachment (b)(6) for the table containing the highlighted questionable results.
Additional Manufacturer Narrative
The patient sample was requested but was not received for investigation.The cause of the event could not be determined.

• Brand Name: TSH ELECSYS E2G 300 V2
• Common Device Name: THYROID-STIMULATING HORMONE ASSAY
• 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
• MDR Report Key: 18384338
• Report Number: 1823260-2023-04171
• Device Sequence Number: 14146465
• Product Code: JLW
• UDI-Device Identifier: 07613336193693
• UDI-Public: 07613336193693
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K190773
• 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): 01/30/2024

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 Catalogue Number: 08443432214
• Device Lot Number: ASKU, 714216
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/30/2024
• 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