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

Model Number 021-105

Device Problems Device Displays Incorrect Message (2591); Device Handling Problem (3265)

Patient Problems Hyperglycemia (1905); Loss of Vision (2139); Dizziness (2194); Diaphoresis (2452)

Event Date 05/09/2023

Event Type  Injury  

Manufacturer Narrative

Similar complaints for these issues 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.Investigation concluded that the device performed as intended by displaying an error message, protecting the user from an erroneous result.

Event Description

On (b)(6) 2023, the lay user/patient contacted lifescan (lfs), alleging that their onetouch ultra2 meter displayed an unknown error message and read inaccurately low compared to their feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that on the night of (b)(6) 2023, they experienced symptoms described as ¿felt off¿ and ¿out balance¿.In response to the symptoms, the patient claimed they measured their blood glucose with the subject meter and obtained what they felt was an inaccurate low reading of ¿149 mg/dl¿.The patient manages their diabetes with 2 types of insulin and a non-insulin injection.The patient denied taking any action regarding their usual diabetes management regimen in response to the alleged low reading and went to sleep.The following morning, the patient claimed they were ¿shaking, lost vision in one of their eyes and felt that they were crashing at the bathroom floor¿.The patient reported that in response to the symptoms, they attempted to measure their blood glucose with the subject meter but were unable to obtain a reading due to the unspecified error message appearing.The patient then attempted to test with a neighbor¿s meter and when an error message also appeared they called 911.The patient claimed they were taken to hospital where a blood glucose result of ¿over 600 mg/dl¿ was obtained on the hospital meter.The patient stated that they were admitted to the hospital for 7 days, 5 of which were in the intensive care unit.Details of treatment received were not provided.At the time of troubleshooting, the cca noted the test strips associated with the complaint had expired.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly experienced a hyperglycemic event requiring hospitalization while using the product.The alleged meter issues could not be ruled out as cause or contributors to the event.

• 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: 17008023
• MDR Text Key: 315998562
• Report Number: 3009698388-2023-00012
• 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
• Report Date: 05/25/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 021-105
• Device Catalogue Number: 021-105
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Female