MAUDE Adverse Event Report: LIFESCAN INC. ONETOUCH ULTRA2; GLUCOSE MONITORING SYS/KIT

Model Number	021-105
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Fatigue (1849); Dizziness (2194); Dysphasia (2195)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Additional 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.Furthermore, 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.
Event or Problem Description
On (b)(6) 2024, the reporter of the lay-user/patient contacted lifescan (lfs) usa, alleging that his mother¿s onetouch ultra 2 meter displayed the meter message ¿apply blood¿ after applying a blood sample.The complaint was classified based on the customer care agent (cca) documentation.The reporter claimed that the alleged issue started on (b)(6) 2024, around 8 am, when his mother tried performing a test before breakfast as she usually does.The patient manages her diabetes with a fixed dose of unspecified insulin (14 units once a day at night) and the reporter denied that the patient took any action in response to the alleged issue.The patient was unable to check her blood glucose levels for two days and started presenting symptoms of ¿feeling dizzy, could not walk, no strength in her body and could not talk and was mumbling¿ on (b)(6) 2024, around 8 am.The reporter called an ambulance, and they took a blood glucose reading of ¿52 mg/dl¿ on an emergency medical services (ems) meter.The patient was brought to the hospital where she received iv fluids and was hospitalized.At the time of troubleshooting, the cca noted that the subject meter was not being used for the first time.The patient had used the correct test strips and was following the correct testing process.After walking through resolving the issue per the owner¿s booklet, the issue remained unresolved.Replacement products have been sent to the patient.This complaint is being reported because the reporter claimed that the patient was unable to test their blood glucose due to the reported issue, reportedly developed symptoms suggestive of a serious injury adverse event and reportedly received hcp treatment for an acute low blood glucose excursion after.

• Brand Name: ONETOUCH ULTRA2
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN INC.; 20 valley stream pkwy; malvern 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: 20754286
• Report Number: 3009698388-2024-00036
• Device Sequence Number: 18464590
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (Y/N): N
• PMA/510(K) Number: K053529
• 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): 11/21/2024

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: 021-105
• Device Catalogue Number: 021-105
• Device Lot Number: Y2308026X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2023
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Female