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 Problems Cramp(s) (2193); Dizziness (2194); Confusion/ Disorientation (2553); No Code Available (3191)

Event Date 05/05/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra2 meter was reading inaccurately high compared to her feelings and/or normal readings.The complaint was classified based on information obtained from the customer service representative (csr) documentation.The patient reported that the alleged inaccuracy issue began at 8:47 p.M., on (b)(6) 2020.The patient claimed obtaining several ¿over 600 mg/dl, hi¿ blood glucose messages and results of ¿593 mg/dl¿ between 8:47 p.M., and 11:01 p.M., on (b)(6) 2020.The patient manages her diabetes with a combination of oral medication (metformin, unspecified dose twice daily) and insulin (lantus, 60 units and, novolog as needed, adjusted according to a sliding scale) and she advised that in response to the alleged elevated readings obtained with the subject device, she administered 35 units of novolog (based on a sliding scale for blood glucose results above 400 mg/dl¿.The patient advised that at around 11:01 p.M., she developed symptoms of feeling ¿dizzy and confused¿ and stated that her ¿left arm cramped up¿ and her ¿hand and arm locked¿.The patient advised that she went to the emergency room (er) where her blood glucose was reportedly measured at ¿57 mg/dl¿ and she was subsequently treated with iv glucose by a health care professional (hcp).The patient stated that an unknown time after treatment with iv glucose, her blood glucose was measured at ¿55 mg/dl¿ and approximately 45 minutes after treatment, her blood glucose was measured using a laboratory device and a result of ¿50 mg/dl¿ was obtained.The patient advised the csr that she was then given juice and a sandwich and was discharged when her blood glucose was measured at ¿86 mg/dl¿.At the time of troubleshooting, the csr confirmed that the unit of measure was set correctly on the subject device at the time of testing.The csr walked the patient through a control solution test and noted that the result obtained fell within the range printed on the test strip vial.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 and required treatment from an hcp after administering insulin based on the alleged elevated 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 ; CH 6300
• MDR Report Key: 10065167
• MDR Text Key: 191430541
• Report Number: 2939301-2020-02644
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• 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: 4539043
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 113