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

Model Number 021-105

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Dizziness (2194); Diaphoresis (2452); Lethargy (2560)

Event Date 08/24/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch ultra 2 meter displayed inaccurately erratic blood glucose results.The complaint was classified based on the customer care agent (cca) documentation.The patient alleged that the product issue began at 5:00 am on (b)(6) 2021.The patient reported that he obtained blood glucose readings of ¿62 and 233 mg/dl¿ on the subject meter, within 20 minutes from each other.The patient manages his diabetes with insulin (levemir - 11 units and lantus ¿ 20 units) and stated that he ate something sweet after he received the first low reading of ¿62 mg/dl¿.The patient claimed that he developed symptoms at 5:05 am of ¿dizziness, sweaty¿ and his ¿stomach hurts¿.He also mentioned that he ¿felt sleepy¿.The patient indicated that because he felt sick, he tested again with the subject meter and received the high reading of ¿233 mg/dl¿.The patient treated himself with 20 units of lantus insulin.He stated that he felt better an hour later.No other blood glucose readings from other devices have been reported.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 established that the test strips had been stored properly, were not open beyond their discard date and had not expired.However, the patient informed the cca that the test strip vial was broken or cracked, but there was no indication of misuse to the product.The cca walked through a control solution test and concluded that the result was in range.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 something sweet based on alleged inaccurate low 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 ; 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: 12478593
• MDR Text Key: 272245912
• Report Number: 3008382007-2021-04235
• 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: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• 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: 4720989
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2021
• 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