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

Model Number	021-098
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Dizziness (2194); Diaphoresis (2452)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the lay user/patient contacted lifescan (lfs) united states, alleging that their onetouch ultra2 meter read inaccurately high compared to their feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began on (b)(6) 2022.The patient mentioned obtaining alleged inaccurate high blood glucose readings of ¿over 400, 121, 471, 328 and 150 mg/dl¿ with the subject meter.The patient manages their diabetes with insulin on a self-adjusting dose.The patient claimed that 2 days after the alleged issue began, they administered an increased dose of insulin (amount not specified) due to the alleged issue and became ¿dizzy and sweaty¿.The patient denied receiving any treatment above and beyond their usual routine of diabetes care and management for the reported symptoms.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter and the correct testing process was being followed.The cca confirmed the test strip vial was intact and the test strips had been stored correct and were not expired or opened past their discard date.The cca noted the patient did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after administering insulin based on alleged inaccurate high results 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: 15433422
• Report Number: 2939301-2022-03097
• Device Sequence Number: 5569955
• Product Code: NBW
• UDI-Device Identifier: 00353885000277
• UDI-Public: 00353885000277
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/15/2022

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: 021-098
• Device Catalogue Number: 021-098
• Device Lot Number: 4844051
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/12/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2022
• 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: Life Threatening
• Patient Sex: Unknown