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

Catalog Number 09315268190

Device Problems Low Test Results (2458); Insufficient Information (3190); Non Reproducible Results (4029)

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

Event Date 10/12/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas 6000 e601 module serial number was (b)(6).The investigation is ongoing.

Event Description

There was an allegation of questionable probnp g2 elecsys results from the cobas 6000 e601 module.The initial result was <50 pg/ml and the repeat result was 35000 pg/ml.On (b)(6) 2023, a new sample from the patient was tested and the initial result was <50 pg/ml.The repeat result was 14595 pg/ml.No information was provided to determine if a questionable result was reported outside of the laboratory.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.A general reagent problem was not present, because the qc prior to the event was within ranges.Medwatch fields d4 lot no and d4 expiration date were updated.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18041605
• MDR Text Key: 327632238
• Report Number: 1823260-2023-03477
• Device Sequence Number: 1
• Product Code: NBC
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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: 12/20/2023

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 Catalogue Number: 09315268190
• Device Lot Number: 732963
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1