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

Model Number 021-105

Device Problem Device Handling Problem (3265)

Patient Problems Dizziness (2194); Presyncope (4410)

Event Date 03/31/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs) united states, alleging that their onetouch ultra2 meter read inaccurately high compared to another device (hospital meter).The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began on (b)(6) 2022 shortly before 12:00 pm.The patient reported obtaining a blood glucose reading of ¿200 mg/dl¿ with the subject meter then ¿80 mg/dl¿ on the hospital meter, performed more than 30 minutes apart.The patient in on insulin pump therapy.The patient claimed that shortly before 12:00 pm on (b)(6) 2022, they administered an increased dose of insulin based on the ¿200 mg/dl¿ reading obtained with the subject meter and shortly after 12:00 pm felt ¿dizzy¿ and became ¿almost unconscious¿.The patient claimed they were treated with food by a family member at the onset of their symptoms and felt better by 12:45 pm.The patient indicated they were taken to the hospital and on arrival, at approximately 1:00 pm, their blood glucose measured ¿80 mg/dl¿ on the hospital meter.No additional treatment was reported.At the time of troubleshooting, the cca confirmed that an approved sample site was used for testing the cca noted the patient did not have control solution available to perform a quality control test.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after administering extra insulin based on an alleged inaccurate high result obtained with the subject meter.

Manufacturer Narrative

The b5 field in the initial 3500a report should also have stated that at the time of troubleshooting, the cca noted that the test strips were being stored incorrectly, outside the vial.The cca educated the patient on the correct storage of the strips.

• Brand Name: OT ULTRA 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN INC.; 20 valley stream pkwy; malvern PA 19355
• 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: 14061136
• MDR Text Key: 289528429
• Report Number: 3009698388-2022-00014
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• 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,Followup
• Report Date: 04/21/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 04/01/2022
• Supplement Dates FDA Received: 04/21/2022
• 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; Required Intervention
• Patient Sex: Male