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 MANUFACTURING INC GLUCOSE
  • 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 MANUFACTURING INC GLUCOSE Back to Search Results
Catalog Number 03L82-21
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
 
Event Description
The customer observed falsely depressed glucose results on the architect c4000 analyzer.The following data was provided: initial 1.13, repeat 8.92 mmol/l.There was no impact to patient management reported.
 
Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of the design history file, and a review of labeling.No adverse trend, non-conformances, potential non-conformances, or deviations were identified for the customer's issue.No return patient sample was available.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GLUCOSE
Type of Device
GLUCOSE
Manufacturer (Section D)
ABBOTT MANUFACTURING INC
1921 hurd drive
irving TX 75038
MDR Report Key9193497
MDR Text Key192389166
Report Number1628664-2019-00669
Device Sequence Number1
Product Code CFR
UDI-Device Identifier00380740006006
UDI-Public00380740006006
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2019
Device Catalogue Number03L82-21
Device Lot Number54288UQ11
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT C4000 ANALYZER.; ARCHITECT C4000 ANALYZER.; LN 02P24-40 SN (B)(4).; LN 02P24-40 SN (B)(4).
-
-