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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 FLEX METER; GLUCOSE MONITORING SYS/KIT
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LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT VERIO FLEX METER; GLUCOSE MONITORING SYS/KIT Back to Search Results
Medical Device Problem Code Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Event or Problem Description
On (b)(6) 2018, the reporter contacted lifescan usa, alleging that the subject meter read inaccurately erratic.The reporter claimed obtaining blood glucose readings of ¿300 and 88 mg/dl¿ with the subject meter, performed within 20 minutes of each other.Based on statistical methodology, the calculated difference of these glucose results exceeds lifescan¿s criteria for precision.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 FLEX METER
Common Device Name
GLUCOSE MONITORING SYS/KIT
Manufacturer (Section D)
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
gubelstrasse 34
zug 6300
SZ  6300
MDR Report Key7319660
Report Number3008382007-2018-00740
Device Sequence Number10790667
Product Code NBW
UDI-Device Identifier00353885010979
UDI-Public00353885010979
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K150214
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other Caregivers
Type of Report Initial
Report Date (Section B) 03/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Other Device ID Number1-3BBSA4F
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date03/04/2018
Device Age5 MO
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/04/2018
Initial Report FDA Received Date03/07/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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