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

Model Number	022-659
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Emotional Changes (1831); Fatigue (1849); Hypoglycemia (1912); Blurred Vision (2137)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3008382007-2022-04310
• Device Sequence Number: 12049790
• Product Code: NBW
• UDI-Device Identifier: 00353885008730
• UDI-Public: 00353885008730
• Combination Product (Y/N): N
• PMA/510(K) Number: K131363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Model Number: 022-659
• Device Lot Number: 4825705
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Female