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

Lot Number	4717822
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Vomiting (2144); Shaking/Tremors (2515); Syncope/Fainting (4411)
Date of Event	10/02/2024
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 lay-user/patient contacted lifescan (lfs) usa, alleging that their onetouch ultra 2 meter was displaying inaccurate erratic readings.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged issue started on (b)(6) 2024, at 10 am.The patient received blood glucose readings of ¿60, 500 and 210 mg/dl¿ on the subject meter, within 20 minutes apart from each other.The patient manages their diabetes with insulin (lantus 25 units) and stated that 5 minutes later they increased their dose of insulin by 31 units in response to the alleged issue.At 11 am that same day, the patient started ¿shaking, vomiting and passed out¿.The patient went to the hospital where they were treated by a health care professional (hcp) with a sugar solution.The patient could not recall the dose that was given.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter, the patient had used an approved sample site to obtain the blood samples and that the patient was following the correct testing procedure.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 patient was using expired test strips.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 after taking an increased dose of insulin based on alleged inaccurate erratic results obtained with the subject meter and reportedly required medical intervention for an acute low blood glucose excursion.

• 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: 20636229
• Report Number: 3009698388-2024-00035
• Device Sequence Number: 12604314
• 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): 11/07/2024

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: 4717822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/07/2024
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown