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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT VERIO2 METER; GLUCOSE MONITORING SYS/KIT
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LIFESCAN EUROPE GMBH OT VERIO2 METER; GLUCOSE MONITORING SYS/KIT Back to Search Results
Lot Number 4430849
Medical Device Problem Code Incorrect, Inadequate or Imprecise Result or Readings (1535)
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 ¿551 and 302 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 VERIO2 METER
Common Device Name
GLUCOSE MONITORING SYS/KIT
Manufacturer (Section D)
LIFESCAN EUROPE GMBH
gubelstrasse 34
zug 6300
SZ  6300
MDR Report Key8177910
Report Number3008382007-2018-03489
Device Sequence Number19107161
Product Code NBW
UDI-Device Identifier00353885008723
UDI-Public00353885008723
Combination Product (Y/N)Y
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K131363
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/13/2018
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
Device Lot Number4430849
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date12/13/2018
Device Age45 MO
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/13/2018
Initial Report FDA Received Date12/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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