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

Catalog Number	08057613190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable digoxin result from the cobas c 503 analytical unit.The initial result was 0.45 g/l for a sample that was expected to have a negative result.As the results did not agree with the patient's clinical picture, the sample was sent to another laboratory where it was tested with abbott methodology and with mass spectrometry.No specific data was provided, but the results were considered to be negative.
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The customer tested other samples that were expected to be negative and the results were between 0.35 and 0.55 ug/l.The customer then replaced the regent and recalibrated the assay.The results were then negative.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation found the last assay calibration before the event was performed on 14-dec-2023.Per product labeling, a full calibration is to be performed after reagent lot change or as required following quality control procedures.In previous investigations, it was found that the recovery of calibrator b with a concentration of 0.5 drifted from 95% to 118% within 7 weeks.The customer data shows a drift of approximately 0.2 ng/ml within 6 -8 weeks.The investigation determined the drift could influence low values around the limit of quantitation (loq) of 0.4 ng/ml and samples with results initially found below the loq when measured shortly after calibration can generate results above the loq if measured at a later point after calibration.

• 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: 18857499
• Report Number: 1823260-2024-00697
• Device Sequence Number: 20876210
• Product Code: KXT
• UDI-Device Identifier: 07613336121214
• UDI-Public: 07613336121214
• 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): 08/21/2024

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: 08057613190
• Device Lot Number: 72471501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 08/22/2024
• 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