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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT VERIO REFLECT METER; GLUCOSE MONITORING SYS/KIT

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LIFESCAN EUROPE GMBH OT VERIO REFLECT METER; GLUCOSE MONITORING SYS/KIT Back to Search Results
Lot Number 5648152
Device Problem Device Handling Problem (3265)
Patient Problem Extreme Exhaustion (1843)
Event Date 03/23/2024
Event Type  Injury  
Event Description
On (b)(6) 2024 the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio reflect meter was reading inaccurately low compared to another meter.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The patient reported that the alleged issue started on (b)(6) 2024 in the morning.The patient stated that she usually gets blood glucose readings in the range of ¿150 mg/dl¿.That morning, even though the patient could not remember the exact reading from the subject meter, she claimed it was in her usual range.The patient manages her diabetes with metformin 500 mg and continued taking her usual dose in response to the alleged issue.At 11 am the patient started feeling ¿exhausted¿ and felt ¿so bad¿ that she had to go to the emergency room (er).At 11:30 am a blood glucose reading of ¿208 mg/dl¿ was obtained on an er meter.The patient received an unspecified type and dose of insulin at the er provided by a health care professional (hcp).During troubleshooting, the cca confirmed that the patient obtained the blood sample from an approved sample site.The cca noted that the patient did not have control solution at the time of the call to test the subject system and explained to the patient how to use control solution.The cca established that the test strips had not expired.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after she received alleged inaccurate low results with the subject meter and reportedly received hcp treatment for an acute high blood glucose excursion after using the product.The subject meter could not be ruled out as a cause or contributor to the event.
 
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Brand Name
OT VERIO REFLECT METER
Type of Device
GLUCOSE MONITORING SYS/KIT
Manufacturer (Section D)
LIFESCAN EUROPE GMBH
dammstrasse 19
zug 6300
SZ  6300
MDR Report Key19093969
MDR Text Key339986737
Report Number2939301-2024-00033
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Lot Number5648152
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date03/25/2024
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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