MAUDE Adverse Event Report: LIFESCAN INC. ONETOUCH ULTRA2; GLUCOSE MONITORING SYS/KIT

Model Number	021-105
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Vertigo (2134); Dizziness (2194); Confusion/ Disorientation (2553)
Date of Event	11/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported issue has been investigated.Investigation concluded that the device performed as intended by displaying an error message, protecting the user from an erroneous result.A device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.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 november 21, 2024, the reporter of the lay user/patient contacted lifescan (lfs) usa, alleging that the patient¿s onetouch ultra 2 meter was displaying the ¿error 5¿ message after applying a blood sample.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and on additional information obtained during review of the call recording.The reporter alleged that the error message began to appear on (b)(6) 2024, at 2:30 pm.However, the reporter informed the cca that the patient felt ¿dizzy, balance was off and disorientated¿ since (b)(6) 2024.On (b)(6) 2024, the patient¿s symptoms started worsening, and they decided to increase their diabetes medication.The patient manages their diabetes with pills (glimepiride 1 mg) with diet and/or exercise and claimed they increased their medication by taking 2 mg of glimeperide instead, expecting this was going to help their ¿high sugar¿.At 11 am that same day, the reporter found the patient¿s symptoms were worse than before and they tried performing a blood glucose test on the subject meter but were unable to get a reading due to the alleged issue.Around 5 pm that day, the patient was taken to the emergency room (er) because their symptoms were getting worse.The reporter stated that they took care of the patient at the er and provided them with different unspecified medications.During review of the call, it was noted that the reporter mentioned that when the patient left the er, their blood sugar was down to ¿160 mg/dl¿.Around midnight, the patient was brought to the intensive care unit (icu) where they stayed until midday on (b)(6) 2024.After that, the patient stayed another night in a normal room and was released from the hospital on (b)(6) 2024.The reporter tried using the subject meter with the patient again and claimed that the subject meter kept showing the error 5 message.During troubleshooting, the cca noted the subject device was not being used for the first time.A replacement meter was sent to the patient.This complaint is being reported because the patient developed symptoms and claimed they were unable to test their blood glucose due to the reported issue, causing a delay to treatment and worsening of symptoms.As a result, the patient received likely medical treatment by a health care professional (hcp) for an acute blood glucose excursion.

• Brand Name: ONETOUCH ULTRA2
• 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: 20860895
• Report Number: 3009698388-2024-00037
• Device Sequence Number: 8627699
• 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): 12/05/2024

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 Model Number: 021-105
• Device Catalogue Number: 021-105
• Device Lot Number: 5817226
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 12/06/2024
• 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; Life Threatening; Required Intervention
• Patient Sex: Unknown