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

Catalog Number	20737836322
Medical Device Problem Codes	Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable dig digoxin result from one patient sample tested on the cobas 8000 cobas c 502 module.The initial result was reported outside of the laboratory.The reporter stated that found a clot in the patient sample upon recheck but they did not receive any clot error alarms, prompting the rerun of the patient sample.The initial result was 0 but was converted and auto-verified to <0.6 ng/ml with a data flag.The repeat result was 1.59 ng/ml.This result was reported as 1.6 ng/ml.The repeat result was deemed correct.
Additional Manufacturer Narrative
The reagent lot number is 700903.The expiration date was not provided.The investigation is ongoing.
Additional Manufacturer Narrative
The customer stated that the issue was resolved when they recentrifuged and reran the patient sample.The investigation reviewed the last calibration performed on (b)(6) 2024.The initial calibration had an alarm which was resolved by recalibration.The investigation reviewed the qc recovery.The qc recovery is within specifications on the date of the event.There is no indication of a reagent or instrument issue.The investigation reviewed the alarm trace.An abnormal aspiration alarm was present on the date of the event which is an indication of a sample issue.The investigation determined the customer's actions resolved the issue.

• 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 46250-0457
• MDR Report Key: 19604748
• Report Number: 1823260-2024-01850
• Device Sequence Number: 7392546
• Product Code: KXT
• UDI-Device Identifier: 04015630915682
• UDI-Public: 04015630915682
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024
• 2 Devices were Involved in the Event: 1 2

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: 20737836322
• Device Lot Number: 700903
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/23/2024
• 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 Age: 60 YR
• Patient Sex: Female