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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 PING METER GLUCOSE MONITORING SYS/KIT

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LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT PING METER GLUCOSE MONITORING SYS/KIT Back to Search Results
Device Problem Failure to Power Up (1476)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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.
 
Event Description
On (b)(6) 2013, the reporter contacted lifescan usa, alleging does not turn on. 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 NameOT PING 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 Key3318321
MDR Text Key11233935
Report Number2939301-2013-01475
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082590
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient
Type of Report Initial
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? No
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? 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

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