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

MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT

  • 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
 

LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT Back to Search Results
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Follow-up # 1 ¿ (10/15/2013). The patient¿s meter has been returned and evaluated by lifescan product analysis on 8/29/2013 and 10/7/2013, respectively, with the following findings: the meter involved with this complaint failed testing. The meter was found to be unable to reproduce an error unknown message. If lifescan obtains additional information regarding this complaint, a follow up report will be submitted. At this time, lifescan considers this matter closed.
 
Event Description
On (b)(6) 2013, the reporter contacted lifescan usa, alleging error unknown. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
The products involved with this complaint have not been returned to life scan at the time of this report. If the products involved are returned, an evaluation shall be completed and a supplemental report will be filed. No conclusions can be made at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOT VERIO IQ METER
Type of DeviceGLUCOSE MONITORING SYS/KIT
Manufacturer (Section D)
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
gubelstrasse 34
zug 6300
SZ 6300
Manufacturer (Section G)
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
gubelstrasse 34
zug 6300
SZ 6300
Manufacturer Contact
m. chiusano / y. wandolski
gubelstrasse 34
zug 6300
SZ   6300
MDR Report Key3318323
MDR Text Key11117696
Report Number2939301-2013-01478
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup
Report Date 08/19/2013
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2013
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2013
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date08/19/2013
Date Manufacturer Received08/19/2013
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number2013-IE-017

-
-