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 Dizziness (2194); Malaise (2359); Sweating (2444); Alteration In Body Temperature (2682)

Event Date 04/30/2020

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 around 9-10 a.M., on (b)(6) 2020.The patient claimed obtaining a blood glucose reading of ¿265 mg/dl¿ with the subject device which she felt was inaccurately high compared to her feelings and/or normal reading.The patient manages her diabetes with insulin (novolin) and advised that she is also taking diroxin.The patient reported that in response to the alleged elevated reading she obtained with the subject device, she adjusted her dose of insulin (specific dose administered, date and time were not provided).The patient advised that approximately an hour and 45 minutes later, she began to ¿feel funny¿ and became ¿dizzy, hot and sweaty¿.The patient denied receiving treatment as a result of the issue but stated that she tested her blood glucose using her mother¿s blood glucose device and claimed obtaining a result of ¿48 mg/dl¿.At the time of troubleshooting, the csr confirmed that the unit of measure was set correctly on the subject device.The csr noted that the patient did not have control solution to test the device at the time of troubleshooting.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 administering an adjusted dose of insulin based on the alleged inaccurately high blood glucose result 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 ; CH 6300
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; GB IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; GB IV2 3ED ; 1463383679
• MDR Report Key: 10065165
• MDR Text Key: 191315455
• Report Number: 3008382007-2020-03934
• 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: 05/04/2020

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: 4583188
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/18/2020
• 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