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

Model Number 023-271

Device Problem Device Handling Problem (3265)

Patient Problems Fatigue (1849); Shaking/Tremors (2515)

Event Date 10/19/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that their onetouch verio flex meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained after medical surveillance (ms) followed up with customer care (cc).The patient reported that the alleged inaccuracy issue began at an unspecified date and time.The patient claimed that she obtained blood glucose readings of ¿200 and 153 mg/dl¿ on the subject device, performed within 20 minutes from each other.The patient manages her diabetes with a combination of oral medication (glipizide and metformin) and did not specify whether she made any changes in response to the alleged inaccurate readings.The patient stated that her doctor advised her to stop taking glipizide a couple of months ago when she obtained a blood glucose reading of ¿30 mg/dl¿, as concluded from follow up with cc.On (b)(6), 2021, at 10:50 am, an unspecified time after the issue occurred the patient developed symptoms of feeling ¿weak and shaking¿.After follow up with cc, ms established that at the time of the call with lfs the patient indicated that when she feels that way, she knows that her sugar is low.The patient denied receiving any medical treatment for the reported symptoms.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter, the patient had used an approved sample site to obtain the blood samples and that the patient was following the correct testing procedure.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.

• 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
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; UK IV2 3ED ; 1463383679
• MDR Report Key: 12756299
• MDR Text Key: 281197798
• Report Number: 3008382007-2021-04264
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 023-271
• Device Catalogue Number: 023-271
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening