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

Model Number 021-105

Device Problem Device Handling Problem (3265)

Patient Problem Hypoglycemia (1912)

Event Date 10/22/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that their onetouch ultra 2 meter was reading inaccurately high compared the same meter and to a hospital meter.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The cca attempted to follow up at ms request, however, was unable to speak to the patient on the phone.The patient reported that the alleged issue began in the evening of (b)(6) 2021.The patient claimed obtaining blood glucose readings of ¿130 and 458 mg/dl¿ on the subject meter, within 20 minutes of each other.The patient informed the cca that he manages his diabetes with insulin (self-adjuster) and did not specify whether he made any changes in response to the alleged erratic readings.The patient stated that the following morning he tested his blood glucose with the subject meter again and obtained a reading of ¿515 mg/dl¿.In response to the high reading, the patient took more insulin and reportedly developed unspecified symptoms after.The patient called the ambulance and went to the emergency room (er) where a blood glucose reading of ¿33 mg/dl¿ was obtained on a hospital meter.The patient indicated that he received treatment in the hospital but did not specify what kind.The patient also informed the cca that his doctor provided a prescription for a new meter since the subject meter was not reading properly.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter and the patient had used an approved sample site to obtain the blood samples.However, the patient informed the cca that the test strips he was using were expired on february 28, 2021.A replacement meter was 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.

• 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: 12791495
• MDR Text Key: 281856069
• Report Number: 2939301-2021-02983
• 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: 11/10/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 021-105
• Device Catalogue Number: 021-105
• Device Lot Number: 4555639
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/22/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2021
• 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