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U.S. Department of Health and Human Services

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

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LIFESCAN EUROPE GMBH OT VERIO FLEX METER; GLUCOSE MONITORING SYS/KIT Back to Search Results
Model Number 023-271
Device Problem Device Handling Problem (3265)
Patient Problems Anxiety (2328); Diaphoresis (2452); Shaking/Tremors (2515)
Event Date 07/04/2022
Event Type  Injury  
Event Description
On (b)(6) 2022 the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio flex meter was reading inaccurately high compared to another meter and to her feelings/usual readings.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and on additional information obtained after the medical surveillance specialist (mss) reviewed the call recording.The patient alleged that the issue began (b)(6) 2022 at midnight.The patient stated that she received a blood glucose reading of ¿130 mg/dl¿ on the subject meter before going to bed and compared it to a reading of ¿77 mg/dl¿ on a freestyle meter, taken more than 30 minutes apart from each other.The patient informed the cca that the subject meter always reads approximately 20 points higher than her freestyle meter.The patient manages her diabetes with pills (glimepiride 2 mg) and exercise and claimed that she decreased her dose of medication to 1 mg since the beginning of (b)(6) 2022, in response to the high readings.The patient stated that since the alleged issue started, she suffered several low blood glucose events with symptoms of ¿shaking, night sweats and anxiety¿ from (b)(6) 2022 onwards.The patient denied receiving any medical treatment for the reported symptoms.During troubleshooting, the cca noted that the subject meter was set to the correct unit of measure and the patient had followed the correct testing process.The cca confirmed that the patient¿s test strips had been stored correctly, were within expiry date and the test strip vial was not cracked or broken.The cca walked through a control solution test and concluded that the result was in range with a reading of ¿125 mg/dl¿.The cca educated the patient on the use of control solution.Replacement products have been sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event while 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 FLEX METER
Type of Device
GLUCOSE MONITORING SYS/KIT
Manufacturer (Section D)
LIFESCAN EUROPE GMBH
gubelstrasse 34
zug 6300
SZ  6300
MDR Report Key15307370
MDR Text Key298767464
Report Number2939301-2022-03089
Device Sequence Number1
Product Code NBW
UDI-Device Identifier00353885010986
UDI-Public00353885010986
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 08/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number023-271
Device Catalogue Number023-271
Device Lot Number4840606
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date08/05/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient SexFemale
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