MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT VERIO 2 METER; GLUCOSE MONITORING SYS/KIT

Model Number 022-659

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

Patient Problems Head Injury (1879); Convulsion/Seizure (4406)

Event Date 07/27/2021

Event Type  Injury  

Event Description

On september 13, 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio2 meter was reading inaccurately high compared to her feelings and/or normal readings.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The patient reported that in the morning of (b)(6) 2021, she took 50 units of lantus insulin and at an unspecified time after she obtained a blood glucose reading of ¿161 mg/dl¿ with the subject meter.The patient manages her diabetes with lantus insulin (50 units twice a day) and takes humalog insulin when she needs it.The patient indicated that she did not make any changes to her usual diabetes management regimen in response to the alleged inaccurate high reading.That same day after the alleged issue occurred, the patient claimed she had a ¿low blood sugar seizure¿ and ¿hit her head¿ as a result.Her husband gave her a glucose injection and then the ambulance arrived.The patient stated that a blood glucose reading of ¿19 mg/dl¿ was obtained on an emergency room (er) meter and that the patient was given glucose gel to raise her blood sugar.The patient was discharged from the hospital at 6 pm that same day.The patient informed the cca that she does not trust her meter anymore, even though the control solution test gave a reading of ¿112 mg/dl¿ and thus fell within range (102-132 mg/dl).During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter.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 signs/symptoms suggestive of a serious injury adverse event after using the product and reportedly received hcp treatment.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT VERIO 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 12510758
• MDR Text Key: 280839658
• Report Number: 2939301-2021-02953
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008730
• UDI-Public: 00353885008730
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022-659
• Device Lot Number: 4651065
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention