Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C4000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  • 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
 

ABBOTT LABORATORIES ARCHITECT C4000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE Back to Search Results
Catalog Number 02P24-01
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2024
Event Type  malfunction  
Manufacturer Narrative
There was no reported impact to patient management.
 
Event Description
The customer stated waste tubing which attached to waste pump popped up and splashed waste material on arm, clothes and eyeglasses from architect c4000 processing module waste pump.The customer was wearing ppe at the time of incident but did not wear gloves at that time.The customer did not seek any medical attention.No further impact to operator.There was no patient involvement.
 
Manufacturer Narrative
An evaan instrument service history review for architect c4000, serial number (b)(6) revealed no contributing factors on or around the date of the complaint.There have been no subsequent contacts from the customer regarding splashing occurrence since the reported incident.Trending review did not identify any trends.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation, no deficiency was identified.Luation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer stated waste tubing which attached to waste pump popped up and splashed waste material on arm, clothes and eyeglasses from architect c4000 processing module waste pump.The customer was wearing ppe at the time of incident but did not wear gloves at that time.The customer did not seek any medical attention.No further impact to operator.There was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARCHITECT C4000
Type of Device
ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
Manufacturer (Section D)
ABBOTT LABORATORIES
1915 hurd drive
irving TX 75038
Manufacturer (Section G)
ABBOTT LABORATORIES
1915 hurd drive
irving TX 75038
Manufacturer Contact
nicole jenne
max-planck-ring 2
post market surveillance
wiesbaden 65205
GM   65205
6122582960
MDR Report Key18788720
MDR Text Key336395958
Report Number3016438761-2024-00118
Device Sequence Number1
Product Code JJE
UDI-Device Identifier00380740003746
UDI-Public00380740003746
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number02P24-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/03/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-