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

Lot Number 5654152

Device Problem Device Handling Problem (3265)

Patient Problem Hyperglycemia (1905)

Event Date 01/19/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, the patient/lay user contacted lifescan (lfs) usa, alleging that her onetouch ultra mini meter displayed inaccurately erratic blood glucose results.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged issue began on (b)(6) between 4 and 5 pm.The patient received alleged erratic blood glucose readings of ¿510, 161, 180 and 150 mg/dl¿ with the subject meter, greater than 20 minutes apart from each other.The patient manages her diabetes with a combination of diabetes medication (metformin and glimepiride) and continued taking her usual dose of medication in response to the alleged issue.However, even though the patient did not develop any symptoms at this time, she decided to visit the emergency room (er) where a blood glucose reading of ¿340 mg/dl¿ was obtained on an er meter that same day, between 4 and 5 pm.At the er the patient was treated by a health care professional (hcp) with insulin.The patient also reported that on (b)(6) 2024, in the morning she felt ¿shakiness¿.No further treatment was reported related to this event.During troubleshooting, the cca confirmed that the patient had used an approved sample site to obtain the blood samples and that the patient was following the correct testing procedure.The cca noted that the patient did not have control solution at the time of the call to test the subject system.The cca established that the test strip vial was intact, that the test strips had been stored properly, were not open beyond their discard date and had not expired.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical treatment provided by an hcp for an acute high blood glucose excursion after she continued taking her usual dose of diabetes medication based on alleged inaccurate erratic results obtained with the subject meter.

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 MINI 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: 18773812
• MDR Text Key: 336182561
• Report Number: 3009698388-2024-00013
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061118
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 5654152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2024
• 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
• Patient Sex: Female