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

Catalog Number 09315268190

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the cobas e 411 was requested but not provided.The customer sent the patient sample to an investigation laboratory.The patient sample was also requested for further investigation.

Event Description

The initial reporter received questionable elecsys nt-probnp g2 assay results from one patient sample tested on the cobas e 411.The initial result was reported outside of the laboratory.On (b)(6)2023, the initial nt-probnp result from the analyzer was < 10 pg/ml.The repeat nt-probnp result from the analyzer was < 10 pg/ml.The clinician determined that the results were different from the clinical findings.The reporter sent the patient sample to an outsourced laboratory for confirmation.On (b)(6)2023, the bnp result from the outsourced laboratory was 119.6 pg/ml.

Manufacturer Narrative

The patient sample was received for investigation.The investigation was able to confirm the customer's results; nt-probnp was not detected in the patient sample using the elecsys probnp ii assay.The investigation noted that two point mutations (r72h and e69d) in the epitope of the detection antibody have already been reported.The investigation tested the patient sample for additional antibodies of mutation.The investigation detected an additional antibody for the reported mutations; the patient sample contained an additional r72h mutation.The mutation caused the false-negative elecsys probnp ii assay result.Product labeling states "in extremely rare cases (global incidence: < 1 in 10 million), patients may show discrepant results when tested with the assay kit (values < lower detection limit) due to a nt-probnp genetic variant.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.".

• Brand Name: ELECSYS PROBNP II
• Type of Device: TEST,NATRIURETIC PEPTIDE
• 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: 17373279
• MDR Text Key: 319829891
• Report Number: 1823260-2023-02394
• Device Sequence Number: 1
• Product Code: NBC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 09315268190
• Device Lot Number: 65182903
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PLEASE REFER TO THE ATTACHMENT PT-83208.
• Patient Age: 85 YR
• Patient Sex: Female