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

Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194)
Date of Event	08/26/2024
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.
Event or Problem Description
On (b)(6) 2024, the lay user/patient¿s daughter contacted lifescan (lfs) united states, alleging that the patient¿s onetouch ultra2 meter read inaccurately erratic and inaccurately high compared to another meter.The complaint was classified based on the customer care agent (cca) documentation, since the reporter disconnected the call and contact information was not available for further information to be obtained.It was not reported when the alleged inaccuracy issue began.The reporter claimed that on an unspecified date, the patient obtained blood glucose results of ¿107 and 96 mg/dl¿ with the subject meter, performed within 20 minutes of each other.Between the tests the patient had eaten breakfast.The reporter mentioned that a normal result for the patient after breakfast is in the ¿130s mg/dl¿ range.It was not reported what medication, if any, the patient takes to manage her diabetes or if she took any action regarding her usual diabetes management regimen as a result of the alleged issue.The reporter claimed that on another further occasion on (b)(6) 2024, the patient obtained a blood glucose result of ¿117 mg/dl¿ with the subject meter after dinner and felt symptoms of ¿low blood sugar¿ described as ¿probably dizzy¿.In response to the symptoms, the reporter claimed the patient went to the emergency room (er) where she received a blood glucose test result of ¿89 mg/dl¿ on the er meter.The time difference between the 2 measurements was more than 30 minutes.It was not reported what medical treatment the patient received.The patient was reportedly admitted to the hospital and received a blood glucose result of ¿94 mg/dl¿ on the er meter at an unspecified time during the stay.No further information was provided.Troubleshooting could not be completed as the reporter disconnected the call.This complaint is being reported because the patient reportedly required hospitalization after obtaining alleged inaccurate results with the subject meter and it is not known what medical treatment the patient received.The subject meter could not be ruled out as a cause or contributor to the event.

• 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: 20186641
• Report Number: 3009698388-2024-00028
• Device Sequence Number: 7003130
• 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): 09/10/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/10/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown