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

Catalog Number	09315284190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys probnp ii (probnp ii) i results from an unspecified number of patient samples tested on the cobas e 801 analytical unit.The reporter was able to provide two patient samples with discrepant results: sample 1 the initial result was 11367 pg/ml.The repeat result was 8047 pg/ml.Sample 2 the initial result was 16036 pg/ml.The repeat result was 11144 pg/ml.The reporter stated that all qc levels were out of the >3 standard deviation range, prompting the rerun of the patient samples.The repeat results were deemed correct.
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation reviewed the last calibration performed on (b)(6) 2024 and the results were within specifications.The investigation reviewed the (b)(6) 2024 and the results were within specifications; the (b)(6) 2024 qc recovery results were within +/- 3 standard deviations (sd).The investigation reviewed the alarm trace and numerous preclean short alarms were observed during the run.The field service engineer (fse) inspected the module and determined the contaminated extra wash station (ews) had caused the event.He then flushed the ews line and reagent lines.He checked the syringes and pinch valves.He performed air purges on the ews and reagent probes and multiple measuring cell preparations.The customer performed qcs with acceptable results.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20237261
• Report Number: 1823260-2024-02685
• Device Sequence Number: 8090158
• Product Code: NBC
• UDI-Device Identifier: 07613336191521
• UDI-Public: 07613336191521
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 10/18/2024

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: 08/31/2025
• Device Catalogue Number: 09315284190
• Device Lot Number: 78343701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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