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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
Lot Number 3360972
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problems Headache (1880); Polydipsia (2604)
Event Date 08/19/2013
Event Type  Injury  
Manufacturer Narrative
The patient¿s meter and test strips have been returned on (b)(6) 2013 and evaluated by lifescan product analysis on (b)(6) 2013 and (b)(6) 2013, respectively, with the following findings: the meter passed all testing with no faults found. The reported issue could not be confirmed. The test strips were also tested and the primary complaint was not confirmed. If lifescan obtains additional information regarding this complaint, a follow up report will be submitted. At this time, lifescan considers this matter closed.
 
Event Description
On (b)(6) 2013, the lay user/patient contacted lifescan (lfs) alleging that her onetouch ultra 2 meter was reading inaccurately erratic. The complaint was classified based on the customer care advocate¿s (cca) documentation. The patient claimed the alleged issue began at approximately 5:33am on the same day she contacted lfs for assistance. She tested back to back on the subject meter and observed values of ¿142, 163 and 151 mg/dl¿ performed within 20 minutes of each other. Based on statistical methodology, the calculated difference of these glucose results falls within the expected value of <
=
20% and/ or <
=
20 mg/dl. It is not known what range the patient considers to be normal. The patient manages her diabetes with an unknown type/dose of insulin (self adjusted) and denied making any changes to her usual diabetes management routine in response to the alleged issue. The patient reported developing symptoms of dry mouth, extreme thirst and headache immediately after testing and denied receiving any form of medical treatment. At the time of troubleshooting the cca confirmed the meter was set to the correct unit of measure, the samples were obtained from the same approved sample site. The subject test strips were unexpired and stored correctly. Replacement products have been sent to the patient and subject products are pending return for investigation. This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury after the alleged meter issue began.
 
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Brand NameOT ULTRA2 METER
Type of DeviceGLUCOSE 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
m. chiusano / y. wandolski
gubelstrasse 34
zug 6300
SZ   6300
MDR Report Key3318324
MDR Text Key21310165
Report Number2939301-2013-01469
Device Sequence Number1
Product Code NBW
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
Type of Report Initial,Followup
Report Date 08/19/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number3360972
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2013
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date08/19/2013
Date Manufacturer Received08/19/2013
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/30/2013 Patient Sequence Number: 1
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