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

Catalog Number	09315284190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(4).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys probnp ii assay results for several patient plasma samples on a cobas e 801 analytical unit instrument.The customer provided examples of discrepant results for 3 patient samples.The doctor questioned the results as they did not fit the clinical picture of the patients.For patient 1, the initial result was 200 pg/ml.The next day, the patient had a result of 20000 pg/ml.The exact date of testing was not provided.For patient 2, the initial result was 1700 pg/ml.The next day, the patient had a result of approximately 5000 pg/ml.The exact date of testing was not provided.On 11-aug-2024, patient 3 had initial result was 1776 pg/ml.The next day, a plasma tube from the patient gave a result of 2239 pg/ml and a serum tube from the patient gave a result of 2363 pg/ml.
Additional Manufacturer Narrative
The calibration and qc recovery data provided was acceptable.It was found that the customer was using the assay as a single screening test for acute myocardial infarction for newly admitted patients.Per product labeling, "this assay is indicated as an aid in the diagnosis of individuals suspected of having congestive heart failure and detection of mild forms of cardiac dysfunction.The test also aids in the assessment of heart failure severity in patients diagnosed with congestive heart failure." the investigation did not identify a product problem.

• Brand Name: ELECSYS PROBNP II
• Common Device Name: NATRIURETIC PEPTIDE TEST
• 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: 20148435
• Report Number: 1823260-2024-02567
• Device Sequence Number: 20924966
• Product Code: NBC
• UDI-Device Identifier: 07613336191521
• UDI-Public: 07613336191521
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• 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): 09/30/2024

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 Catalogue Number: 09315284190
• Device Lot Number: 783437
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/30/2024
• 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 Sex: Unknown