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

Model Number 021-105

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Coma (2417)

Event Date 06/25/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that the patient¿s onetouch ultra 2 meter was reading inaccurately high.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.A follow up call was made with the patient by customer care (cc), however the patient was not willing to provide more information about the event.The patient claimed that the alleged issue began approximately 3 or 4 months ago, around (b)(6) 2021, at an unspecified time.The patient stated that they received unspecified inaccurate high readings with the subject meter.The patient manages their diabetes with insulin (self-adjuster) and reported that they increased the dose of insulin in response to the high readings.At an unspecified time after the alleged issue occurred, the patient went into a ¿diabetic coma¿.The patient informed the cca that they went to the hospital where they received unspecified treatment.During troubleshooting, the cca walked the patient through a retest and the control solution was in range with a reading of ¿135 mg/dl¿ on the subject meter.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 taking an increased dose of insulin based on alleged inaccurate high results obtained with the subject meter.There is insufficient information to rule out the contribution of the subject meter to the event.

• Brand Name: OT ULTRA 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 12859251
• MDR Text Key: 281856864
• Report Number: 2939301-2021-02989
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 021-105
• Device Catalogue Number: 021-105
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening