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

Lot Number 4708672

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Extreme Exhaustion (1843); Fatigue (1849); Dizziness (2194); Cognitive Changes (2551)

Event Date 08/01/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging her onetouch verio reflect meter was reading erratically high.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The patient reported that the alleged inaccuracy issue began on (b)(6) 2021, around 12 am.The patient claimed that she obtained blood glucose readings of ¿350 and 141 mg/dl¿ on the subject device, performed within 20 minutes from each other.The patient manages her diabetes with insulin (self-adjuster) and stated that she took a dose of insulin based on the high reading of ¿350 mg/dl¿.A couple of minutes after 12 am, the patient started to develop symptoms of feeling ¿weak, dizzy, delirious¿ and ¿she kept on falling asleep and waking up¿.The patient advised that she ¿fixed the situation¿ by eating a lot of carbohydrates to get her blood glucose levels up again.No medical intervention or other blood glucose readings have been reported.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter and the patient had followed the correct testing process.The cca established that the test strips had been stored properly, were not open beyond their discard date, had not expired and the vial was not cracked or broken.The cca walked through a control solution test and concluded that the result was in range.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after taking an increased dose of insulin based on alleged inaccurate high results obtained with the subject meter.

• Brand Name: OT VERIO REFLECT METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 12285202
• MDR Text Key: 265598142
• Report Number: 2939301-2021-02916
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4708672
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening