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

Lot Number 5648343

Device Problem Device Handling Problem (3265)

Patient Problems Hypoglycemia (1912); Nausea (1970); Dysphasia (2195); Shaking/Tremors (2515); Alteration in Body Temperature (4568)

Event Date 02/01/2024

Event Type  Injury  

Manufacturer Narrative

Similar complaints for this issue were trended including the reported meter.It was concluded that the number of complaints for the meter did not breach thresholds indicative of a systemic issue.In addition, 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 february 6, 2024, the lay user/patient contacted lifescan (lfs) united states, alleging that her onetouch ultra2 meter read inaccurately high compared to another meter.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy occurred on february 1, 2024, at 7:00 pm.The patient reported obtaining blood glucose readings of ¿107 mg/dl¿ with the subject meter and ¿40 mg/dl¿ on the other device, performed more than 30 minutes apart.The patient manages her diabetes with humulin insulin on a self-adjusting dose (56-58 units).The patient stated that she took her usual dose of insulin in response to the ¿107 mg/dl¿ reading then developed symptoms of ¿unable to speak clearly, shakes, feeling very hot and nausea¿.The patient stated that she was taken to the emergency room at 10:00 pm where she was treated with a glucose infusion and given food and drink.The patient stated that her blood glucose was measured on arrival at the er but was unable to recall the result obtained.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 received medical intervention for an acute low blood glucose excursion after taking insulin based on an alleged inaccurate high result obtained with the subject meter.

• 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: 18692350
• MDR Text Key: 335193446
• Report Number: 3009698388-2024-00010
• Device Sequence Number: 1
• Product Code: NBW
• 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
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 5648343
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2024
• 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