• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ROCHE DIAGNOSTICS ELECSYS PROBNP II; NATRIURETIC PEPTIDE TEST Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18743461
MDR Text Key336398081
Report Number1823260-2024-00491
Device Sequence Number1
Product Code NBC
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K060373
Number of Events Reported1
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 Number09315276160
Device Lot Number72243101
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/29/2024
Initial Date FDA Received02/20/2024
Supplement Dates Manufacturer Received03/19/2024
Supplement Dates FDA Received03/25/2024
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 Number1
Patient Age80 YR
Patient SexFemale
-
-