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

Model Number 021-105

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Irritability (2421); Diaphoresis (2452)

Event Date 03/17/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch ultra2 meter was reading inaccurately high compared to his feelings and/or normal readings.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and additional information obtained when cca reviewed the initial call recording.The patient reported that the alleged inaccuracy issue began between 8:00pm and 11:00pm on (b)(6) 2021.The patient claimed obtaining a blood glucose reading of ¿325 mg/dl¿ with the subject device which he felt was inaccurately high compared to his feelings and/or normal readings.The patient manages his diabetes with a combination of medications (insulin: tougel 100 units oral: janumet 1000 half pill).The patient reported that, although he did not feel bad, he took a whole pill of janumet in response to the alleged result.The patient reported that on an unspecified time after obtaining the alleged inaccurately high blood glucose reading, he developed symptoms of ¿agitated and sweating¿.He retested his blood and obtained a blood glucose result of 102mg/dl, however, was feeling unwell.The patient reported that he went to a friends¿ house and again retested his blood glucose and obtained a result of 62mg/dl.The patient stated that he self-treated with food (he ate an orange).At the time of troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject device at the time of testing.The cca also noted that the patient did not have control solution available at the time of the call to test the subject system.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 for an acute low blood glucose excursion after administering medication based on the alleged inaccurately high blood glucose readings obtained on the subject device.

• 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: 11670301
• MDR Text Key: 245563771
• Report Number: 2939301-2021-02849
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): Y
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• 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
• Device Lot Number: 4692073
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening