MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TROPONIN T GEN 5 STAT ASSAY; TROPONIN SUBUNIT IMMUNOASSAY METHOD

Catalog Number	08469865160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 6000 e601 module is (b)(6).The troponin t stat assay orders were reviewed and the customer confirmed that they have a separate sample id number for all troponin t stat assay orders.The customer reviewed the test order for the reported patient sample id and noted that it should only have had a comprehensive test with no troponin t stat order and the troponin t stat order should have been on another sample id number.The customer stated that they believed the troponin t stat was manually ordered for the reported patient sample and that a dilution of 1:10 was ordered by mistake.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable elecsys troponin t g5 stat result from one patient sample tested on the cobas 6000 e601 module.The questionable result was not reported outside of the laboratory.The reporter stated that they did not intentionally run a dilution, but the result showed a ratio of 10.The initial result was deemed high prompting the rerun of the patient sample.The initial result from the other module was 36.46 ng /l.The first repeat result from the module was 94.85 ng /l.The second repeat result from the other module was 35.47 ng/l.The third repeat result from the other module was 34.77 ng/l.The result of 36 ng/l was deemed correct.
Additional Manufacturer Narrative
The investigation reviewed the qc recovery; the qc recovery was within -2 standard deviations (sd) and is within specifications.There was no indication of a performance issue with the reagent.The field applications specialist inspected the event and determined that the event was caused by the customer's manual ordering of the patient sample with a completed troponin t stat result; the customer also accidentally ran the patient sample and was unaware that there was an assigned dilution.The customer was advised to rerun the patient sample and a correct result was obtained.The investigation determined the event was due to the customer's product handling (manually ordered the sample with dilution when assay should not be run with a dilution).

• Brand Name: ELECSYS TROPONIN T GEN 5 STAT ASSAY
• Common Device Name: TROPONIN SUBUNIT IMMUNOASSAY METHOD
• 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: 18701926
• Report Number: 1823260-2024-00426
• Device Sequence Number: 6194516
• Product Code: MMI
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

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 Expiration Date: 01/31/2025
• Device Catalogue Number: 08469865160
• Device Lot Number: 74311200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 03/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN.; FUROSEMIDE.; NITROGLYCERINE.
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic