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

Model Number	DIG
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration and the quality control recovery are within the acceptable range, showing no indication of a reagent or instrument performance issue.The cause of the event could not be determined.The issue is consistent with sample interference.For further investigation, the sample was requested but not returned.The customer stated that there is no sample material left for additional investigation.
Event or Problem Description
The initial reporter complained of discrepant results for one patient sample tested for digoxin (dig) on a cobas pro c 503 analytical unit.The initial result of the first sample tested on the c503 module was < 0.3¿g/l.This result was reported outside of the laboratory where it was questioned by the doctor as it was not plausible.The sample was repeated on a cobas c6000 system with a result of < 0.3¿g/l.The initial result for the second sample (new blood drawn on 28-oct-2022) tested on the c503 module was < 0.3¿g/l.The sample was repeated on a cobas c6000 system with a result of < 0.3¿g/l.The patient was sent to another laboratory where a new sample was obtained and the result from a cobas 8000 system was 0.76 ug/l.A third sample was obtained on 03-nov-2022.A serum sample and a lithium heparin sample were obtained at the same time.The serum sample was tested on the c503 module with a result of 0.3 ug/l.The lithium heparin sample was sent to the other laboratory and the result from a cobas 8000 system was 1.0 ug/l.The high results from the other laboratory (1.0 g/l and 0.76 g/l) were considered to be correct.The c503 module serial number was (b)(4).The serial numbers for the cobas 8000 and the cobas 6000 systems were requested but not provided.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15910805
• Report Number: 1823260-2022-03847
• Device Sequence Number: 2519663
• Product Code: KXT
• UDI-Device Identifier: 07613336121214
• UDI-Public: 07613336121214
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 12/02/2022

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 Model Number: DIG
• Device Catalogue Number: 08057613190
• Device Lot Number: 618797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 12/02/2022
• 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
• Patient Age: 24 MO
• Patient Sex: Female