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 Visual Disturbances (2140); Shaking/Tremors (2515); Alteration in Body Temperature (4568)

Event Date 02/13/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra2 meter was reading inaccurately high compared to her 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 the cca listened to the call recording.The patient reported that the alleged issue began at 9:30 am., on (b)(6) 2021.The patient claimed obtaining a blood glucose reading of ¿263 mg/dl¿ with the subject meter which she felt was inaccurately high compared to her feelings and/or normal readings.The patient manages her diabetes with insulin (lantus ¿ self adjuster) and reported that she increased her dose to 22 units of lantus insulin after she obtained the alleged inaccurate high reading on the subject meter at 9:30 am.The patient advised that two hours after receiving the alleged high reading she started to develop symptoms of ¿feeling hot, shaking and her vision was grey¿.The patient reported that in response to the symptoms she developed, she measured her blood glucose again with the subject device and claimed obtaining a result of ¿89 mg/dl¿ on the subject device and immediately tested on another device (contour next1) and received a result of ¿67 mg/dl¿.She then once again tested on the subject device and obtained a reading of ¿241 mg/dl¿.There was no report of any medical treatment/intervention received as a result of the alleged issue.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter, the patient had used an approved sample site to obtain the blood samples and that the patient was following the correct testing procedure.The cca noted that the patient did not have control solution at the time of the call to test the subject system.The cca established that the test strip vial was intact, that the test strips had been stored properly, were not open beyond their discard date and had not expired.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.

• 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: 11382593
• MDR Text Key: 242843117
• Report Number: 3008382007-2021-04125
• 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: 02/13/2021

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: 4668247
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2021
• Initial Date FDA Received: 02/25/2021
• 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