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

Model Number	021-098
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Codes	Hyperglycemia (1905); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra2 meter would not power on and she was unable to test her blood glucose.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged power issue began on the morning of (b)(6) 2020.The patient manages her diabetes with isophane insulin (self-adjuster).The patient denied making any changes to her usual diabetes management regimen when she was unable to perform a blood glucose test due to the alleged issue.The patient reported that at midday on (b)(6) 2020, she started to feel "thirsty and urinate constantly." in response to the symptoms, the patient claimed she tested her blood glucose on a neighbor's meter (ultra mini) and result of "over 600 mg/dl" was obtained.She then contacted her doctor who advised her to go to the emergency room (er) immediately.The patient claimed she was treated at the er with intravenous (iv) fluids and insulin.At the time of troubleshooting, the cca noted that the subject meter was not being used for the first time and that there was no indication of misuse to the device.The cca confirmed the correct test strips were being used for testing.The cca noted the meter would power on manually when the power button was pressed but not when a test strip was inserted.Replacement products were sent to the patient.This complaint is being reported because the patient claims she was unable to test her blood glucose due to the reported issue and reportedly received medical intervention for an acute high blood glucose excursion after the alleged meter issue began.
Additional Manufacturer Narrative
The lay user/patient¿s meter has been returned and evaluated by lifescan product analysis with the following findings: one of the batteries in the returned meter was found to be depleted.This battery was replaced and the meter powers on with the button and strip insertion.In addition, 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.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• Brand Name: OT ULTRA 2 METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, 6300 ; SZ 6300
• MDR Report Key: 10844064
• Report Number: 3008382007-2020-04048
• Device Sequence Number: 16884006
• Product Code: NBW
• UDI-Device Identifier: 00353885000277
• UDI-Public: 00353885000277
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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: 4563459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 63 YR