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

Catalog Number 09315276160

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

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

Event Date 01/29/2024

Event Type  malfunction  

Event Description

The initial reporter complained of a discrepant low result for 1 patient sample tested for elecsys probnp ii (probnp ii) on a cobas e 601 module.The initial result was < 36 pg/ml with a data flag.This result was reported outside of the laboratory where the doctor requested repeat testing as the result did not correspond to the patient¿s clinical picture.The repeat result was 11890 pg/ml.This result was believed to be correct.The sample was repeated for confirmation on the other line of the e601 module and the result was 11458 pg/ml.

Manufacturer Narrative

The e601 module serial number was (b)(6).

Manufacturer Narrative

Section d, device identification was updated.Relevant fields of sections d and g were updated.The probnp ii reagent lot number was 72243101 with an expiration date of 31-aug-2024.The field service engineer (fse) visited the customer site and indicated there was a sample quality issue.Probnp precision results were within range and instrument performance testing was acceptable.Calibration was last performed on 23-jan-2024 with acceptable results.Qc was acceptable.There is no indication of a reagent or instrument performance issue.The customer used a centrifugation time of 5 minutes at 5000 revolutions per minute (rpm).Based on the customer's sample tube type, this time is too short and the speed is too fast.Procell/cleancell short alarms and sample short alarms were observed on the alarm trace data.The sample short alarms indicate poor sample quality.Based on the information provided, the investigation determined the event was consistent with preanalytical handling issues.

• 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: 18743461
• MDR Text Key: 336398081
• Report Number: 1823260-2024-00491
• 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: 03/25/2024
• 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: 09315276160
• Device Lot Number: 72243101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/25/2024
• 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: 80 YR
• Patient Sex: Female