MAUDE Adverse Event Report: ROCHE DIAGNOSTICS DIGOXIN; ENZYME IMMUNOASSAY, DIGOXIN

Catalog Number	20737836322
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable digoxin result from the cobas 8000 cobas c 502 module.The customer alleged an interference.The result for the first sample was 0.66 ng/ml.The physician questioned the result as the patient was not given digoxin as part of the medical treatment.The sample was repeated on a cobas e8010 analyzer and the result was <0.2 ng/ml with a data flag.A new sample was collected from the patient and had the same results.No specific data was provided.
Additional Manufacturer Narrative
The cobas 8000 cobas c 502 module serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The specific cause of the event could not be determined.

• Brand Name: DIGOXIN
• Common Device Name: ENZYME IMMUNOASSAY, DIGOXIN
• 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: 18456179
• Report Number: 1823260-2024-00054
• Device Sequence Number: 7066540
• Product Code: KXT
• UDI-Device Identifier: 04015630915682
• UDI-Public: 04015630915682
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K961824
• 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): 04/08/2024

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: 04/30/2025
• Device Catalogue Number: 20737836322
• Device Lot Number: 72471401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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