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 Hypoglycemia (1912); Diaphoresis (2452)

Event Date 08/16/2022

Event Type  Injury  

Manufacturer Narrative

Similar complaints for this issue were trended for the test strip lot.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.

Event Description

On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs) united states, alleging that her onetouch ultra2 meter read inaccurately high compared to another meter (doctor¿s meter; brand unspecified).The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy first started on (b)(6) 2022, between 3:00 am and 6:00 am.The patient reported obtaining blood glucose readings of between ¿300 to 400 mg/dl¿ with the subject meter compared to ¿57 mg/dl¿ on the other device, performed more than 30 minutes apart.The patient stated that she manages her diabetes with oral medication (glipizide 10mg) and took her usual dose of medication in response to the alleged issue.The patient reported developing symptom of ¿sweating¿ after the alleged issue began and proceeded to the emergency room (er) where her blood glucose measured ¿57 mg/dl¿ on the doctor¿s meter at 6:00 am.The patient stated she was at the er for 12 hours, was treated with orange juice and advised to schedule an appointment with her doctor.At the time of troubleshooting, the cca confirmed an approved sample site was used for testing.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after obtaining alleged inaccurate high blood glucose readings with the subject meter.The subject meter could not be ruled out as a cause or contributor to the event.

Manufacturer Narrative

The lay user/patient¿s meter has been returned and evaluated by lifescan product analysis with the following findings: the meter passed performance testing with no faults found.The reported issue could not be confirmed.In addition, a device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• 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: 15263277
• MDR Text Key: 298284534
• Report Number: 3009698388-2022-00043
• 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: 01/27/2023

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: 4777056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 08/20/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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