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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 VERIO2 METER; GLUCOSE MONITORING SYS/KIT

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LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT VERIO2 METER; GLUCOSE MONITORING SYS/KIT Back to Search Results
Lot Number 4079970
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Itching Sensation (1943); Nausea (1970); Dizziness (2194)
Event Type  Injury  
Event Description
On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio 2, meter was showing an unknown error message.The complaint was classified based on customer service representative (csr) documentation.The patient stated the meter issue began on (b)(6) 2017, at 10pm.The patient reported that she manages her diabetes with a combination of diabetes medications ¿metformin and novolog¿ and denies making any changes to her usual diabetes management regimen.The patient stated that on (b)(6) 2017 at 3pm she developed symptoms of ¿dizziness, nausea and itchiness¿.The patient reported that she self-treated the symptoms by taking ¿2 metformin pills¿.At the time of troubleshooting, the csr walked the patient through a retest and the alleged meter issue was resolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs and/or symptoms that may have meet lfs¿ criteria for a serious injury reportable adverse event after the alleged product issue began.
 
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Brand Name
OT VERIO2 METER
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 Key6543312
MDR Text Key74356181
Report Number3008382007-2017-20752
Device Sequence Number1
Product Code NBW
UDI-Device Identifier00353885008730
UDI-Public(01)00353885008730
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Lot Number4079970
Other Device ID Number1-2IZSAO8
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date04/28/2017
Device Age23 MO
Initial Date Manufacturer Received 04/28/2017
Initial Date FDA Received05/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age62 YR
Patient Weight113
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