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 Hyperglycemia (1905); Dizziness (2194)

Event Date 10/08/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the patient/lay user contacted lifescan (lfs) usa alleging that her onetouch ultra 2 meter read inaccurately high compared to her feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation since the patient was unable to be contacted for further information.The patient reported that the alleged issue began at 1 pm on (b)(6) 2022.The patient claimed obtaining a blood glucose reading of ¿490 and 300 mg/dl¿ with the subject meter which she felt was inaccurately high compared to her feelings and/or normal readings.The patient manages her diabetes with diet and exercise only and denied taking any action in response to the alleged issue.Immediately after the alleged issue occurred at 1 pm, the patient developed symptoms of feeling ¿dizziness and lightheaded¿.The patient stated that due to the symptoms she went to the hospital on (b)(6) 2022.It was not reported if the patient received any medical treatment at the hospital.During troubleshooting, the cca noted that the subject meter was set to the correct unit of measure.However, the patient informed the cca that the test strips she was using were expired on may 31, 2021.The cca educated the patient about the expiry date and explained that the patient had to get some new test strips.A control solution was sent to the patient.Medical surveillance was unable to reach the patient to clarify if the patient believed the device contributed to the adverse event.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event and received possible medical intervention for an acute blood glucose excursion while using the product.The subject meter could not be ruled out as a cause or contributor to the event.

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.

• 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: 15751444
• MDR Text Key: 303236250
• Report Number: 3009698388-2022-00058
• 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: 11/08/2022

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
• Device Lot Number: 4579557
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/08/2022
• 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): Hospitalization; Life Threatening
• Patient Sex: Female