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

Catalog Number	09315268160
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	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) replaced the syringe seals and the pinch tubing.The fse performed horizontal adjustments on the probe to ensure proper positioning during aspiration and dispensing.He also performed sample/reagent and sipper probe priming.No hardware issues were identified.Investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 5 patients' plasma samples tested with elecsys probnp g2 assay on a cobas e411 immunoanalyzer serial number (b)(4).The customer stated that the pbnp samples were flagged as short samples, but the sample volume appeared ok.So they tested the samples again in hitachi cups and the initial results for sample 1, sample 2, sample 3, sample 4 and sample 5 were all < 50 pg/ml.The customer questioned the intial results and repeated the samples.The repeat results: sample 1: 7769 pg/ml.Sample 2: 2117 pg/ml.Sample 3: 7915 pg/ml.Sample 4: 863.2 pg/ml.Sample 5: 317.8 pg/ml.No questionable results were reported outside the laboratory.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
Calibration and qc were acceptable.Multiple "sample short" and "sample liquid level detection (lld) noise" errors were observed on the alarm trace data.These are indicators of possible poor sample quality.A general reagent problem can be excluded.The customer did not provide further information for the investigation.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16868694
• Report Number: 1823260-2023-01512
• Device Sequence Number: 6099973
• Product Code: NBC
• UDI-Device Identifier: 07613336191569
• UDI-Public: 07613336191569
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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 Expiration Date: 06/30/2023
• Device Catalogue Number: 09315268160
• Device Lot Number: 64177201
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 06/28/2023
• 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