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

Lot Number	5726069
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hypoglycemia (1912); Syncope/Fainting (4411)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On october 10, 2024, a reporter for the lay user/patient contacted lifescan (lfs) united states, alleging that the patient¿s onetouch ultra2 meter read inaccurately high compared to her feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that the alleged meter inaccuracy occurred at an unspecified time on (b)(6) 2024.The reporter claimed the patient obtained an alleged inaccurate high blood glucose reading of ¿500 mg/dl¿ with the subject meter.In response to the elevated reading, the reporter indicated that the patient took an increased dose of 10 units of insulin (type unspecified) then 30 minutes later ¿passed out in the car¿.The reporter called an ambulance and when they arrived, the patient¿s blood glucose read ¿22 mg/dl¿ on the ambulance meter.The reporter indicated that the patient was given a glucagon injection.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca confirmed the test strip vial was intact, and the test strips had been stored correctly and were not expired or opened past their discard date.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after administering treatment based on an alleged inaccurate high reading obtained with the subject meter.

• Brand Name: OT ULTRA 2 METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN INC; 20 valley stream parkway; malvern PA 19355
• MDR Report Key: 20518717
• Report Number: 2939301-2024-00074
• Device Sequence Number: 8768088
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

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: 5726069
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown