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

Model Number	021-924
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, the lay-user/patient¿s son contacted lifescan (lfs) (b)(4), alleging that the patient¿s onetouch ultra mini meter read inaccurately high compared to another meter (emergency medical services meter).The complaint was classified based on the customer care agent (cca) documentation, since the reporter was unable to be contacted for additional information.The reporter stated that the alleged meter inaccuracy occurred on (b)(6), 2021.The reporter claimed the patient was ¿hypoglycemic; almost in a coma and when the patient¿s blood glucose was measured with the subject meter a reading of 79 mg/l was obtained.The emergency medical services (ems) were contacted for assistance.The reporter claimed the patient¿s blood glucose was measured with the ems meter and a reading of 39 mg/dl was obtained.The time difference between the readings was not provided.The reporter claimed the patient was treated by ems with intravenous (iv) glucose.No hospitalization was reported.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted the test strips associated with the complaint had expired by several years.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly received medical treatment for an acute low blood glucose excursion while using the product.The alleged meter issue could not be ruled out as a cause or contributor to the event.

• Brand Name: OT ULTRA MINI METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 11586663
• Report Number: 3008382007-2021-04137
• Device Sequence Number: 4297115
• Product Code: NBW
• UDI-Device Identifier: 00353885008136
• UDI-Public: 00353885008136
• Combination Product (Y/N): Y
• PMA/510(K) Number: K061118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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: 021-924
• Device Catalogue Number: 021-924
• Device Lot Number: 3168992
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 03/29/2021
• 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: 76 YR