MAUDE Adverse Event Report: LIFESCAN INC. OT ULTRA 2 METER; GLUCOSE MONITORING SYS/KIT

Model Number 021-105

Device Problem Device Alarm System (1012)

Patient Problems Hyperglycemia (1905); Blurred Vision (2137); Dizziness (2194)

Event Date 10/13/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs) usa, alleging that his onetouch ultra 2 meter displayed the error message ¿apply blood¿ after applying a blood sample.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the subject meter is not working and only displays a blood drop.The patient did not report when the issue exactly started however, he indicated that he has a problem with the subject meter for approximately one year.The patient manages his diabetes with a combination of medication (januvia 100 mg - once a day, metformin 500 mg ¿ once at night and levothyroxine 3 pills) and claimed that he increased his dose of medication by taking a pill of metformin during the day.On (b)(6) 2022, at an unspecified time after the alleged issue occurred, the patient developed symptoms of feeling ¿dizzy, sugar goes up and blurry vision¿.The patient denied that he received any treatment for the reported symptoms but indicated that he can go talk to his doctor.At the time of troubleshooting, the cca noted that the subject meter was not being used for the first time and that the correct test strips were being used for testing.The cca confirmed that the patient was following the correct testing procedure however, the issue remained unresolved during troubleshooting.Replacement products were sent to the patient.This complaint is being reported because the patient claims he was unable to test his blood glucose due to the reported issue and reportedly developed symptoms suggestive of a serious injury adverse event after the alleged meter issue began.

Manufacturer Narrative

Similar complaints for this issue were trended including the reported meter and the test strips.It was concluded that the number of complaints for the meter and test strips 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 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 ULTRA 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN INC.; 20 valley stream pkwy; malvern PA 19355
• 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: 15695972
• MDR Text Key: 302686896
• Report Number: 3009698388-2022-00057
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053529
• 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: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 021-105
• Device Catalogue Number: 021-105
• Device Lot Number: 4780780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/15/2023
• 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): Life Threatening
• Patient Sex: Male