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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT VERIO TEST STRIPS; GLUCOSE MONITORING SYS/KIT
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LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT VERIO TEST STRIPS; GLUCOSE MONITORING SYS/KIT Back to Search Results
Lot Number 4046374
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
On (b)(6) 2016, the reporter contacted lifescan usa, alleging closure seal issue.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.
 
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Brand Name
OT VERIO TEST STRIPS
Type of Device
GLUCOSE 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
mariano chiusano
gubelstrasse 34
zug 6300
SZ   6300
MDR Report Key5992638
MDR Text Key56099605
Report Number3008382007-2016-50780
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 09/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot Number4046374
Other Device ID Number1-SPA5A5
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date09/23/2016
Date Manufacturer Received09/23/2016
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
Type of Device Usage Initial
Patient Sequence Number1
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