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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 3402107
Device Problems High Test Results (2457); Calibration Problem (2890)
Patient Problems Headache (1880); Shaking/Tremors (2515)
Event Date 08/12/2013
Event Type  Injury  
Manufacturer Narrative
Lifescan (lfs) has requested return of the subject product(s) for evaluation. If the product(s) are returned, lfs will evaluate it/them and inform fda of product(s) that do not pass inspection in a supplemental report.
 
Manufacturer Narrative
Follow-up # 1 ¿ (09/04/2013). The patient¿s meter and test strips (b)(4) have been returned on 8/28/2013 and 9/4/2013, respectively, and evaluated by lifescan product analysis on 8/30/2013 and 9/4/2013, respectively, with the following findings: the meter passed all testing with no faults found. The reported issue could not be confirmed. The subject test strips (b)(4) involved with this complaint passed testing. The reported issue could not be confirmed. Secondary test strips (b)(4) unrelated to the complaint 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 he had difficulty calibrating the code on his onetouch ultra2 meter which read inaccurately high compared to his feelings/ normal blood glucose results. The complaint was classified based on the customer care advocate (cca) documentation. The alleged issue began on the morning of (b)(6) 2013. The patient reported a blood glucose result of ¿224 mg/dl¿ with the subject meter. The patient manages his diabetes with oral medications (type/ amount not specified). It is not known if the patient made changes to his usual management routine. About 2-3 minutes after the start of the alleged issue, the patient claimed he felt symptoms of shaky and headache. The patient denied receiving medical treatment. At the time of troubleshooting, the cca noted the subject meter was set to the correct unit of measurement. The cca walked the patient through correctly coding the subject meter to match the test strips. Quality control testing was performed which fell within specifications. Replacement products were sent to the patient. This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury after the alleged meter issues 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 Key3318327
MDR Text Key10921801
Report Number2939301-2013-01494
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 08/12/2013
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 Number3402107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2013
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date08/12/2013
Date Manufacturer Received08/12/2013
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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