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

Catalog Number	20737836322
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for three samples collected from the same patient and tested with dig digoxin on a cobas 6000 c (501) module.The sample results did not agree with the clinical picture of the patient.The results from the first two samples were reported outside of the laboratory.The result from the third sample was not reported outside of the laboratory.Prior to the complained samples, a sample from the patient resulted in a digoxin value of 0.83 nmol/l on (b)(6) 2022.On or after (b)(6) 2021, the patient started taking urea medication.The digoxin levels of the patient rose after the introduction of this medication.The first complained sample resulted in a digoxin value of 1.62 nmol/l on (b)(6) 2022.The second complained sample resulted in a digoxin value of 1.89 nmol/l on (b)(6) 2022.This measurement was performed one day after digoxin medication was discontinued.The third complained sample resulted in a digoxin value of 1.52 nmol/l on (b)(6) 2022.The serial number of the c 501 analyzer is (b)(4).
Additional Manufacturer Narrative
Initial investigations have determined that urea does not interfere with the digoxin assay.No interfering substance was identified in the medications the patient was taking.The investigation could not identify a product problem.The cause of the event could not be determined.Per product labeling: "there is the possibility that other substances and/or factors may interfere with the test and cause unreliable results.As with many mouse monoclonal antibody-based immunoassays, this assay may experience interference with samples containing human anti-mouse antibodies (hama).Samples suspected of containing hama (e.G., from patients with history of mouse monoclonal antibody exposure) should be tested by an alternate method.".
Additional Manufacturer Narrative
The sample collected prior to the complained samples (dated (b)(6)2022) and the second complained sample (dated (b)(6)2022) were repeated at the customer site in parallel with lc-ms/ms testing of the samples.The sample dated (b)(6)2022 was repeated on the c 501 analyzer, resulting in a digoxin value of 0.8 nmol/l.When tested using the lc-ms/ms method, the result was 0.8 nmol/l.The sample dated (b)(6)2022 was repeated on the c 501 analyzer, resulting in a digoxin value of 1.6 nmol/l.When tested using the lc-ms/ms method, the result was 1.9 nmol/l.Further investigations concluded that interference in the samples could be excluded as the c 501 results were confirmed by the lc-ms/ms method.The assay is performing within specifications.
Additional Manufacturer Narrative
The component code has been updated.

• Brand Name: DIG 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13453478
• Report Number: 1823260-2022-00296
• Device Sequence Number: 14986846
• Product Code: KXT
• UDI-Device Identifier: 04015630915682
• UDI-Public: 04015630915682
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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,Followup
• Report Date (Section B): 03/17/2022

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: 01/31/2022
• Device Catalogue Number: 20737836322
• Device Lot Number: 51849301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 02/10/2022; 02/23/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 02/14/2022; 03/17/2022
• 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: REFER TO THE ATTACHMENT FOR MEDICATIONS
• Patient Age: 76 YR
• Patient Sex: Female