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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 3714703
Device Problem Peeled/Delaminated (1454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
On (b)(6) 2015, the reporter contacted lifescan (b)(4) , alleging peeling test strip.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 Key4448812
MDR Text Key5387738
Report Number2939301-2015-02736
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K093745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 01/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot Number3714703
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date01/15/2015
Date Manufacturer Received01/15/2015
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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