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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 ULTRA2 METER; GLUCOSE MONITORING SYS/KIT

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LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT ULTRA2 METER; GLUCOSE MONITORING SYS/KIT Back to Search Results
Event Type  Injury  
Event Description
On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch ultra 2 meter was testing in settings mode.The complaint was classified based on customer service representative (csr) documentation.The patient reported that the meter issue began on november 29, 2017.He reported that he manages his diabetes with insulin (no adjustments), and made no changes to his normal diabetes management regimen in response to the alleged issue.The patient alleges that on an unknown date/time after the product issue began, he developed symptoms of ¿eyes got bad, bad eye sight¿.In response to the symptoms the patient stated that he attended his doctor¿s office and was treated with ¿levemir insulin 50 units¿.During troubleshooting the csr noted this was not the first time the product was being used.The csr walked through a retest with the patient and the issue was resolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms and received treatment for a serious injury adverse event after the alleged product issue began.There is insufficient information to rule out the contribution of the subject meter to the event.
 
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Brand Name
OT ULTRA2 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 Key7107370
MDR Text Key94474380
Report Number3008382007-2017-23545
Device Sequence Number1
Product Code NBW
UDI-Device Identifier00353885008372
UDI-Public00353885008372
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053529
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other Caregivers
Type of Report Initial
Report Date 12/08/2017
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Other Device ID Number1-99SMXF
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date12/08/2017
Device Age7 MO
Initial Date Manufacturer Received 12/08/2017
Initial Date FDA Received12/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2017
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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