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

Lot Number	5808489
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Vomiting (2144); Dizziness (2194)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, a reporter for the lay user/patient contacted lifescan (lfs) united states, alleging that the patient¿s onetouch ultra2 meter would not power on.The complaint was classified based on the customer care agent (cca) documentation.The reporter indicated that the alleged power issue began around (b)(6) 2024.The patient manages their diabetes with oral medication, diet and exercise.The reporter claimed the patient continued to follow their usual diabetes management routine in response to the alleged issue.The reporter indicated that 1 day prior to the start of the alleged issue, the patient began to develop symptoms of ¿weakness in legs, dizziness and vomiting¿.However, 2 days after the start of the alleged issue the patient¿s symptoms worsened.The reporter claimed the patient was taken to the hospital where they were treated with 2 doses of insulin (type/amount not reported) and the patient felt better afterwards.The reporter claimed the patient obtained a blood glucose result of ¿128 mg/dl¿ on the doctor¿s meter after receiving the treatment.At the time of troubleshooting, the cca noted that the subject meter was not being used for the first time and there was no indication of misuse of the device.The cca confirmed the correct test strips were being used for testing.The cca noted the meter would power on manually when the power button was pressed and when a new test strip was inserted.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute high blood glucose excursion after the alleged issue began.The subject meter could not be ruled out as a cause or contributor to the event.
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.

• Brand Name: OT ULTRA 2 METER
• Common Device Name: 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: 20274664
• Report Number: 3009698388-2024-00029
• Device Sequence Number: 3505405
• 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): 09/20/2024

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: 5808489
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 09/20/2024
• 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
• Patient Sex: Unknown