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

Catalog Number	08057613190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable digoxin results from the cobas c 503 analytical unit.The initial result was 0.00 ng/ml with a data flag.The sample was repeated 10 times and the result was always 0.00 ng/ml with a data flag.The sample was repeated on a unicel dxi 800 access immunoassay system (beckman) instrument and the result was 0.33 ng/ml.
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: 20369679
• Report Number: 1823260-2024-02886
• Device Sequence Number: 17859801
• Product Code: KXT
• UDI-Device Identifier: 07613336121214
• UDI-Public: 07613336121214
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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): 10/18/2024

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: 08057613190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 10/18/2024
• 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