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

Catalog Number 07027664190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.The event occurred in (b)(6).

Event Description

The initial reporter complained of questionable results for 1 patient tested for elecsys probnp ii immunoassay on a cobas 8000 e 801 module serial number (b)(4).Compared to the bnp result.The probnp ii result was 5 pg/ml and was reported outside of the laboratory.The physician questioned the result as it did not match the patient's clinical condition.On (b)(6) 2019 the bnp result was 1169.3 pg/ml.The method was not provided.The customer remeasured the probnp ii and the result was less than the sensitivity.There was no allegation of an adverse event.

Manufacturer Narrative

Upon investigation of the patient sample, an interference against a component of the reagent was confirmed.This interference is covered in product labeling: in extremely rare cases (global incidence: < 1 in 10 million), patients may show discrepant results when tested with the assay kit (values < limit of detection) 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 IMMUNOASSAY
• Type of Device: TEST,NATRIURETIC PEPTIDE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8794242
• MDR Text Key: 151191387
• Report Number: 1823260-2019-02625
• Device Sequence Number: 1
• Product Code: NBC
• Combination Product (y/n): N
• PMA/PMN Number: K072437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

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 Catalogue Number: 07027664190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 06/28/2019
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1