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

Catalog Number	20737836322
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 6000 c501 module is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable dig digoxin results from one patient sample tested on the cobas 6000 c501 module.The initial result was not reported outside of the laboratory.The initial result from the module with the patient sample in a tube was 0.30 ng/ml with a data flag.The first repeat result from the module with the patient sample in a tube was 0.40 ng/ml.The second repeat result from the module with the patient sample in a cup was 0.35 ng/ml.The third repeat result from the module with the patient sample in a cup was 0.59 ng/ml.The fourth repeat result from another c 501 with the patient sample in a cup was 0.50 ng/ml.The fifth repeat result from another c 501 with the patient sample in a cup was 0.51 ng/ml.
Additional Manufacturer Narrative
The investigation reviewed the calibration data.The investigation noted that the first calibration performed on 13-oct-2023 at 2:18 pm failed with errors; the second calibration at 3:22 pm was successful.The first calibration on 20-oct-2023 failed with errors; the second calibration was successful.The investigation reviewed the qc results on the date of event from the digital laboratory management software.The qc levels 1 and 2 were out of range on the date of event.A hardware performance check was performed; two assays had borderline to expected values.The investigation determined the event was consistent with a sample carryover due to a partially clogged sample probe.Product labeling states "daily maintenance - cleaning sample probe, reagent probes, ise probe and ise sipper nozzle at the end of analysis each day, clean the outside of the pipetter probes (sample probe, reagent probes, ise probe) and of the ise sipper to remove residual solution and precipitation.This is a combined maintenance procedure for both ise and photometric unit.".

• 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: 18111345
• Report Number: 1823260-2023-03573
• Device Sequence Number: 7863245
• Product Code: KXT
• UDI-Device Identifier: 04015630915682
• UDI-Public: 04015630915682
• 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): 01/02/2024

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: 11/30/2024
• Device Catalogue Number: 20737836322
• Device Lot Number: 70090301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 01/02/2024
• 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 Sex: Unknown