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

Model Number	021-105
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Fall (1848); Shaking/Tremors (2515); Convulsion/Seizure (4406)
Date of Event	11/22/2024
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 contacted lifescan (lfs) usa alleging that their onetouch ultra 2 meter displayed the calcode and did not provide a reading.The complaint was classified based on the customer care agent (cca) documentation since the patient could not be reached by phone for follow-up questions.It was not reported when the alleged issue started.The patient claimed that every time they tried performing a blood glucose test, they saw code 25 and then a message appeared that they could not read because they had cataract surgery.The patient did not provide information on how they manage their diabetes, nor did they report whether they made any changes in response to the alleged issue.At an unspecified time after the alleged issue occurred, the patient developed symptoms of ¿head shaky, falling back like having convulsions¿.The patient had to go to the emergency room (er) where a blood glucose reading of ¿535 mg/dl¿ was obtained on a hospital meter.The patient was treated by a health care professional (hcp) with insulin and an iv.During troubleshooting, the cca noted that the subject meter was not being used for the first time and the issue was resolved on the call.As a courtesy the cca sent replacing test strips to the patient.This complaint is being reported because the patient claimed they were unable to test their blood glucose due to the reported issue, reportedly developed symptoms suggestive of a serious injury adverse event and received medical intervention by a health care professional (hcp) for an acute high blood glucose excursion after.The subject device could not be ruled out as a cause or contributor to the event.

• 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: 20898699
• Report Number: 3009698388-2024-00038
• Device Sequence Number: 9053773
• 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): 12/10/2024

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
• Device Model Number: 021-105
• Device Catalogue Number: 021-105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 12/10/2024
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown