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 Blurred Vision (2137); Polydipsia (2604)

Event Date 06/21/2023

Event Type  Injury  

Event Description

On june 22, 2023, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch verio flex meter was reading inaccurately high compared to another meter.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and based on information obtained after customer care (cc) reviewed the call recording.The patient alleged that the issue started on (b)(6) 2023, at 7:00 pm when he received a blood glucose reading of ¿300 mg/dl¿ on the subject meter.The patient manages his diabetes with a combination of medication (novolog insulin - 32 units 3 times per day, metformin 100 mg ¿ twice a day and tresiba flextouch ¿ 96 units once per day) and he denied that he took any action in response to the alleged issue.The patient did mention that he started drinking water.At an unspecified time after the alleged issue occurred, the patient ¿could not see very well and was thirsty¿.The patient reported that he called 911 and the emergency medical services (ems) checked his blood glucose and obtained a reading of ¿30 mg/dl¿ on an ems meter.The patient claimed that he was treated by the ems with a ¿special insulin¿ at an unspecified time and date.During the review of the call recording the cca noted that the patient stated that he received the ¿special insulin¿ in the ambulance to bring him up to 200 until he arrived at the hospital.During troubleshooting, the cca confirmed that the patient had used an approved sample site to obtain the blood samples.The cca noted that the patient did not have control solution at the time of the call to test the subject system.The cca established that the test strips had expired on august 31, 2022.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 and received medical intervention for an acute low blood glucose excursion after the alleged product issue began.There is insufficient information to rule out the contribution of the subject meter to the event.

Manufacturer Narrative

Similar complaints for this issue were trended including the reported meter.It was concluded that the number of complaints for the meter did not breach thresholds indicative of a systemic issue.In addition, similar complaints for this issue were trended for the test strip lot.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.

Manufacturer Narrative

The lay user/patient¿s meter has been returned and evaluated by lifescan product analysis with the following findings: the meter has passed performance testing with no faults found.The reported issue could not be confirmed.In addition, a device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• 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: 17275453
• MDR Text Key: 318545082
• Report Number: 3008382007-2023-00038
• Device Sequence Number: 1
• Product Code: NBW
• 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,Followup
• Report Date: 10/18/2023

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
• Device Lot Number: 4697616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention; Life Threatening
• Patient Sex: Male