MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PROBNP II, N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE; TEST,NATRIURETIC PEPTIDE

Catalog Number	07027664190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer received questionable low elecsys probnp ii immunoassay results for one patient from a cobas e 801 module.The serial number was requested but was not provided.For multiple samples from the patient, the elecsys probnp result was always <5 pg/ml, but the bnp results were between 20-49 pg/ml.The results were reported outside of the laboratory.The physician believed "there should be heart load in the patient" since the patient has obstructive hypertrophic cardiomyopathy.There was no allegation of an adverse event.
Additional Manufacturer Narrative
The sample was tested and the initial pro-bnp result was replicated.The investigation is ongoing.
Additional Manufacturer Narrative
The customer provided sample was tested and a pro bnp mutation could be confirmed.The investigation is ongoing.
Additional Manufacturer Narrative
It was determined the confirmed mutation is extremely rare and so far has only found in japanese populations.Product labeling for the assay documents this limitation.

• Brand Name: PROBNP II, N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE
• Common Device Name: TEST,NATRIURETIC PEPTIDE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7722122
• Report Number: 1823260-2018-02224
• Device Sequence Number: 1369475
• Product Code: NBC
• UDI-Device Identifier: 04015630939756
• UDI-Public: 04015630939756
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/19/2018

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: 07027664190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/23/2018
• Supplement Date Received by Manufacturer: 06/23/2018; 06/23/2018; 06/23/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 08/09/2018; 08/28/2018; 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMIODARONE; BETA-BLOCKER; CALCIUM ANTAGONIST
• Patient Age: 83 YR