MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS PROBNP II; IMMUNOCHEMISTRY ANALYZER

Model Number E411 RACK

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Low Readings (2460)

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

Event Date 01/25/2023

Event Type  malfunction  

Event Description

The initial reporter complained of qc issues after replacing the probnp reagent on a cobas e 411 immunoassay analyzer.After noticing the qc issue, the customer repeated patient samples and there was a difference in results.The following are examples of discrepant results for 5 patient samples.Note: the unit of measure used by the customer is not clear.This information has been requested but has not been provided.Patient 1 initial result was 129.The repeat result was 87.Patient 2 initial result was 631.The repeat was 832.Patient 3 initial result was 2615.The repeat was 3436.Patient 4 initial result was 642.The repeat was 859.Patient 5 initial result was 449.The repeat was 585.The questionable results were reported outside of the laboratory.The probnp reagent lot number and expiration date were not provided.

Manufacturer Narrative

The suspect medical device was updated.Applicable fields of sections d and g were updated.The e411 analyzer serial number was (b)(6).

Manufacturer Narrative

Calibration was acceptable.Third-party qc was acceptable.The measuring cell was last replaced on 15-jun-2022.When a new reagent kit with the same lot number was loaded onto the instrument, qc was performed.Qc results indicated a new calibration was required.After calibration, qc was within range.The initial patient results were obtained before the new calibration was performed; the repeat results were obtained after recalibration.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS PROBNP II
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• 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: 16405849
• MDR Text Key: 310156049
• Report Number: 1823260-2023-00522
• Device Sequence Number: 1
• Product Code: NBC
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 05/12/2023

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: 03/30/2024
• Device Model Number: E411 RACK
• Device Catalogue Number: 09315268190
• Device Lot Number: 651829
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 04/17/2023; 05/08/2023
• Supplement Dates FDA Received: 04/21/2023; 05/12/2023
• 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