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

Lot Number	5728656
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Diaphoresis (2452); Confusion/ Disorientation (2553)
Date of Event	08/05/2024
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.
Event or Problem Description
On (b)(6) 2024, the patient/lay user contacted lifescan (lfs) usa, alleging that their onetouch ultra 2 meter was reading inaccurately high.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The patient reported that the alleged issue started on (b)(6) 2024, at 9 pm.The patient stated that they received a blood glucose reading of ¿250 mg/dl¿ on the subject meter.The patient manages their diabetes with insulin (humalog 39 units and levemir 42 units) and claimed that they reduced their food intake and only took a light meal in response to the results received that evening.On (b)(6) 2024, at 2 am, the patient woke up feeling ¿sweaty and extremely confused¿.The patient¿s wife called the paramedics, and a health care professional (hcp) treated the patient with iv glucose.Before treatment a blood glucose reading of ¿39 mg/dl¿ was obtained on an emergency medical service (ems) meter.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 were within their expiry date.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 treatment by an hcp after decreasing their food intake based on alleged inaccurate high results obtained with the subject meter.

• Brand Name: OT ULTRA 2 METER
• 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: 19988476
• Report Number: 3009698388-2024-00027
• Device Sequence Number: 7087326
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 08/14/2024

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 Lot Number: 5728656
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/14/2024
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown