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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT ULTRA PLUS REFLECT METER; GLUCOSE MONITORING SYS/KIT
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LIFESCAN EUROPE GMBH OT ULTRA PLUS REFLECT METER; GLUCOSE MONITORING SYS/KIT Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
On (b)(6) 2019, the reporter contacted lifescan (b)(4), alleging that the subject meter read inaccurately erratic.The reporter claimed obtaining blood glucose readings of ¿70 and 180 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 ULTRA PLUS REFLECT METER
Type of Device
GLUCOSE MONITORING SYS/KIT
Manufacturer (Section D)
LIFESCAN EUROPE GMBH
gubelstrasse 34
zug 6300
SZ  6300
Manufacturer (Section G)
LIFESCAN EUROPE GMBH
gubelstrasse 34
zug 6300
SZ   6300
Manufacturer Contact
oyinkan donaldson
gubelstrasse 34
zug 6300
SZ   6300
MDR Report Key8825629
MDR Text Key152512969
Report Number3008382007-2019-03037
Device Sequence Number1
Product Code CGA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial
Report Date 07/23/2019
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
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 07/23/2019
Initial Date FDA Received07/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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