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

Catalog Number 08836736190

Device Problem Low Test Results (2458)

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

Event Date 09/29/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys probnp ii immunoassay results from 1 patient on a cobas 6000 e601 module.The initial probnp result was < 10.00 pg/ml.The test result on an abbott analyzer was 1243 pg/ml.The e601 analyzer was recalibrated.The sample was repeated and the result was < 10.00 pg/ml.The sample was diluted to 1:2, 1:5, 1:10, 1:20, and 1:40.All diluted repeat results were < 10.00 pg/ml.A peg sedimentation method was performed and the result was < 10.00 pg/ml.The e601 results were reported outside of the laboratory.The abbott analyzer result was deemed correct.The e601 analyzer serial number is (b)(4).

Manufacturer Narrative

The patient sample was provided for investigation.The investigation found that the customer's e601 probnp results could be reproduced on the investigational e601 analyzer.It was also found that there is no interference with the streptavidin component of the reagent or heterophilic antibodies with "normal" hbt treatment.The investigation is ongoing.

Manufacturer Narrative

Calibration was last performed on the day of the event.Qc data was acceptable on the day of the event.The investigation found that the patient's bnp result did not change after treatment with heterophilic blocking tubes.The presence of an interfering factor in the patient sample could not be shown.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: ELECSYS PROBNP II STAT IMMUNOASSAY
• Type of Device: 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: 15657938
• MDR Text Key: 307157115
• Report Number: 1823260-2022-03315
• Device Sequence Number: 1
• Product Code: NBC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092649
• 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,Followup
• Report Date: 02/23/2023

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: 01/31/2023
• Device Catalogue Number: 08836736190
• Device Lot Number: 56186800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/24/2022
• Supplement Dates Manufacturer Received: 11/28/2022; 01/16/2023
• Supplement Dates FDA Received: 12/20/2022; 02/23/2023
• 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
• Patient Age: 86 YR
• Patient Sex: Female