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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT ULTRAMINI METER; GLUCOSE MONITORING SYS/KIT
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LIFESCAN EUROPE GMBH OT ULTRAMINI METER; GLUCOSE MONITORING SYS/KIT Back to Search Results
Lot Number 4506683
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) 2019, the reporter contacted lifescan united states, alleging that the subject meter read inaccurately erratic.The reporter claimed obtaining blood glucose readings of ¿282 and 168 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 ULTRAMINI METER
Common Device Name
GLUCOSE MONITORING SYS/KIT
Manufacturer (Section D)
LIFESCAN EUROPE GMBH
gubelstrasse 34
zug 6300
SZ  6300
MDR Report Key8863936
Report Number3008382007-2019-03202
Device Sequence Number11448712
Product Code NBW
UDI-Device Identifier00353885011464
UDI-Public00353885011464
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
K061118
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) 08/02/2019
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 Number4506683
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/02/2019
Initial Report FDA Received Date08/06/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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