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 Fatigue (1849); Hypoglycemia (1912); Blurred Vision (2137); Dizziness (2194); Shaking/Tremors (2515)

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.

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 another meter (hospital meter).The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained by the medical surveillance specialist after reviewing the call recording, since the patient was unwilling to answer additional questions during a follow-up attempt.The patient was unable to recall when the alleged meter inaccuracy began.On an unspecified date, the patient reported obtaining blood glucose readings of ¿426 mg/dl¿ with the subject meter and ¿28 mg/dl¿ on a hospital meter, performed more than 30 minutes apart.The patient manages her diabetes with a combination of insulin (toujeo, humalog) on a self-adjusting dose and a non-insulin injection (trulicity).The patient denied making any changes to her usual diabetes management regimen due to the alleged issue.The patient reported developing symptoms of feeling ¿shaky, no energy, dizzy and very blurry vision¿ at an unspecified date and time as a result of the alleged issue and had to attend the emergency room for treatment.During the call, the patient claimed her blood glucose measured ¿40 something mg/dl¿ on the hospital meter on arrival at hospital and was treated with iv fluids and glucose gel.At the time of troubleshooting, the cca noted that an approved sample site was used for testing replacement product was sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute low blood glucose excursion while using the product.The subject meter could not be ruled out as a cause or contributor to the event.

• 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: 13419621
• MDR Text Key: 286676235
• Report Number: 3009698388-2022-00008
• 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
• Report Date: 02/01/2022

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: 01/09/2022
• Initial Date FDA Received: 02/01/2022
• 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