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

Model Number 021-105

Device Problem Device Alarm System (1012)

Patient Problems Chills (2191); Diaphoresis (2452); Ambulation Difficulties (2544); Presyncope (4410)

Event Date 02/26/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra2 meter was displaying a hi message result over 600mg/dl.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The patient reported that the alleged issue began at an unknown time on (b)(6) 2021, and has been ongoing.The patient manages her diabetes with self-adjusted insulin 3 dosages of novalog 10 units and 120 units of tresibal, daily and she advised that in response to the alleged issue, she began to guess her medication intake (dose not specified).The patient reported than on (b)(6) 2021, an unspecified time after the alleged issue occurred, she started feeling bad ¿very sweaty, shivering, felt like she couldn't walk, as well as feeling like she was going to faint¿.The patient reported that she self-treated by drinking a ¿small coke¿ and felt better.The patient denied testing her blood glucose on another device.At the time of troubleshooting, the cca established that the product was not being used for the first time.The cca walked through resolving the issue; and noted that the patient was using expired test strips (2018-05-31).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 obtaining the hi blood glucose message 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
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; UK IV2 3ED ; 1463383679
• MDR Report Key: 11548169
• MDR Text Key: 243925203
• Report Number: 3008382007-2021-04133
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K053529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• 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: 4100128
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 84