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

Lot Number 5637330

Device Problem Device Handling Problem (3265)

Patient Problems Hypoglycemia (1912); Dysphasia (2195); Confusion/ Disorientation (2553)

Event Date 02/21/2024

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 march 20, 2024, the lay user/patient¿s daughter contacted lifescan (lfs) united states, alleging that the patient¿s onetouch ultra2 meter read inaccurately high compared to another meter.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained by the medical surveillance specialist (mss) after reviewing the call recording.During the call, the reporter stated that the patient started to obtain high readings with the subject meter on (b)(6) , 2024.The reporter claimed that on the morning of (b)(6) 2024, at 8:26 am, she found the patient ¿acting like a child and incoherent¿ and the patient received a result of ¿260 mg/dl¿ with the subject meter.The reporter called the emergency medical services (ems) for assistance.Whilst ems were in attendance, the reporter claimed the patient received a result of ¿299 mg/dl¿ with the subject meter compared to ¿52 mg/dl¿ on the ems meter, performed 40 mins apart.The reporter claimed the patient started coming around after being given something by ems and was taken to the hospital by ambulance and was admitted.The reporter claimed the patient was treated with orange juice, ginger ale, crackers and blood pressure medication.The reporter did not recall the patient being treated with iv therapy or injections.The patient was discharged at 12:30 pm that same day with a blood glucose level of ¿125 mg/dl¿.During the call, the reporter claimed that prior to the onset of the patient¿s symptoms, the patient had last tested her blood glucose with the subject meter the night before at 9:57 pm and received a result of ¿439 mg/dl¿ and had taken her usual dose of novolin 70/30 insulin (15 units).At the time of troubleshooting, the cca walked the reporter through a control solution test and the result fell outside the specified control solution range printed on the test strip vial.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly experienced an acute low blood glucose excursion requiring hospitalization after the alleged product issue began.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: 19068473
• MDR Text Key: 339681046
• Report Number: 3009698388-2024-00016
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• 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: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 5637330
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2024
• 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): Hospitalization