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

Model Number 022-659

Device Problem Device Handling Problem (3265)

Patient Problems Emotional Changes (1831); Fatigue (1849); Hypoglycemia (1912); Blurred Vision (2137)

Event Date 09/01/2020

Event Type  Injury  

Event Description

On may 19, 2022, a reporter for the lay-user/patient contacted lifescan (lfs) united states, alleging that the patient¿s onetouch verio2 meter read inaccurately high compared to another meter.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that the alleged meter inaccuracy occurred in (b)(6) 2020.The reporter claimed the patient obtained a blood glucose result which was ¿higher than usual¿ with the subject meter then a blood glucose result which was ¿low¿ on an unspecified emergency room (er) meter; exact results were not provided.The tests were performed more than 30 minutes apart.The patient manages their diabetes with insulin on a self-adjusting dose.The reporter claimed the patient took more insulin in response to the elevated reading obtained with the subject meter then started to develop symptoms of ¿blurry vision, weak and emotional¿.The reporter claimed the patient proceeded to the er where they obtained a blood glucose result which was ¿low¿ on the er meter and were treated with food and drink.At the time of troubleshooting, the cca noted that an approved sample site was used for testing.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute low blood glucose excursion after administering an increased dose of insulin based on an alleged inaccurate high result obtained with the subject meter.

Manufacturer Narrative

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.

• 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
• 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: 14504595
• MDR Text Key: 292730219
• Report Number: 3008382007-2022-04310
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008730
• UDI-Public: 00353885008730
• Combination Product (y/n): N
• PMA/PMN Number: K131363
• 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: 05/25/2022

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: 022-659
• Device Lot Number: 4825705
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 05/26/2022
• 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): Required Intervention; Life Threatening
• Patient Sex: Female