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

Catalog Number 09315268160

Device Problems Low Test Results (2458); No Apparent Adverse Event (3189)

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

Event Date 01/22/2024

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 analyzer alarms and questionable probnp g2 elecsys result from the cobas 6000 e601 module.One example was provided of an initial result of 36 pg/ml with a data flag.The repeat result from another cobas e601 analyzer was 973.7 pg/ml.The questionable result was not reported outside the laboratory.The repeat result was believed correct as the patient's previous probnp result was 894 pg/ml.

Manufacturer Narrative

The field service engineer found an issue with the sample probe.He replaced the sample probe and adjusted the liquid level detection (lld) voltage.The customer performed qc.The investigation determined the service actions resolved the issue.

• Brand Name: ELECSYS PROBNP II
• Type of Device: NATRIURETIC PEPTIDE TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18685320
• MDR Text Key: 335125985
• Report Number: 1823260-2024-00394
• Device Sequence Number: 1
• Product Code: NBC
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2024
• 2 Devices were Involved in the Event: 1 2

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: 09315268160
• Device Lot Number: 00722426
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 02/16/2024
• 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
• Treatment: ALBUTEROL; ASPIRIN; ENOXAPARIN; FERROUS SULFATE; FUROSEMIDE; INSULIN; LIDOCAINE PATCH; MUCINEX; NEBIVOLOL; OXYCODONE; TRAZODONE
• Patient Age: 78 YR
• Patient Sex: Male