MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH ELECSYS PROBNP II; NATRIURETIC PEPTIDE TEST

Catalog Number	09315284190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys probnp ii immunoassay ver.2.1 on a cobas e 801 analytical unit (serial number(b)(4).The sample initially resulted in a probnp value of 18.3 pg/ml and this value was reported outside of the laboratory to medical personnel.The result was questioned since it did not agree with the patient's clinical picture.The sample was repeated, resulting in a value of 5299 pg/ml, which was deemed correct and matched the patient's clinical picture.A second sample collected from the patient resulted in a probnp value of > 5000 pg/ml.
Additional Manufacturer Narrative
Facility name was provided as "barrualde-galdakaoko erakunde sanitario integratua organizacion sanitaria integrada barrualde-galdakao".
Additional Manufacturer Narrative
The last calibration was performed on (b)(6) 2022 and calibration signals were within expectations.Per product labeling, renewed calibration is recommended after 12 weeks when using the same reagent lot.Controls were within specified ranges on the day of the event.Calibration and controls do not point to a general reagent or instrument problem.The sample clotting time was shorter than recommended by the tube manufacturer.Upon review of the alarm trace, an abnormal sample aspiration alarm occurred on the day of the event.On analysis of images from the sample foam detection camera, a red blood cell strand was visible when the tube was first measured.A film was also observed on the surface of the sample.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with incorrect pre-analytic sample handling.

• Brand Name: ELECSYS PROBNP II
• Common Device Name: NATRIURETIC PEPTIDE TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer (Section G): ROCHE DIAGNOSTICS; 9115 hague road; na; indianapolis IN 46250 0457
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16375795
• Report Number: 1823260-2023-00466
• Device Sequence Number: 17956635
• Product Code: NBC
• UDI-Device Identifier: 07613336191521
• UDI-Public: 07613336191521
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K210546
• 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): 04/10/2023

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 Catalogue Number: 09315284190
• Device Lot Number: 630011
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 04/10/2023
• 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