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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 VERIO IQ METER GLUCOSE MONITORING SYS/KIT

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LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT Back to Search Results
Lot Number 3459781
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Weakness (2145); Numbness (2415)
Event Type  malfunction  
Manufacturer Narrative
The lfs product(s) has/have been requested for return to lifescan for evaluation. If the product is returned, an evaluation shall be completed and a supplemental report will be filed. No conclusions can be made at this time.
 
Manufacturer Narrative
Follow-up # 1 ¿ (10/23/2013) the patient¿s meter has been returned and evaluated by lifescan product analysis on (b)(4) 2013 and (b)(4) 2013, respectively, with the following findings: the meter passed all testing with no faults found. The reported issue could not be 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) in (b)(4) alleging his onetouch verioiq meter was displaying a ¿error strip fill problem, test strip or meter problem¿. The complaint was classified based on the customer care advocate (cca) documentation. The patient was reported a few minutes prior to the start of the issue, the patient felt symptoms of feeling weakness and numbness. The patient reported a few months prior to contacting lfs the alleged issue first began. It is unclear if the patient made any changes to his normal diabetes management routine. The patient denied receiving any treatment in response to his symptoms. At the time of troubleshooting, the issue was not resolved with a retest. Replacement products were sent to the patient. There is no indication that the subject meter caused or contributed to a serious injury. The patient¿s symptoms do not meet lfs¿ criteria for a serious injury. The patient did not report any blood glucose readings, symptoms or treatment suggestive that an acute complication of diabetes occurred. However this complaint is being reported because the alleged issue was not resolved at the time of troubleshooting.
 
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Brand NameOT VERIO IQ 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 Key3318320
MDR Text Key10921352
Report Number2939301-2013-01473
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K110637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2013
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2013
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number3459781
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2013
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date08/17/2013
Date Manufacturer Received08/17/2013
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

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