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

Device Problem Loss of Power (1475)

Patient Problems Hypoglycemia (1912); Diaphoresis (2452)

Event Date 12/17/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay user/patient¿s neighbor contacted lifescan (lfs), alleging that the patient¿s onetouch ultramini meter would not power on.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that the alleged power issue began on (b)(6) 2022.The patient manages his diabetes with 2 types of insulin.In response to the alleged issue, the reporter indicated that on (b)(6) 2022, the patient stopped his bolus insulin (20 units 3 times a day at mealtimes) but continued to take his basal insulin (80 units once a day).The reporter informed the cca that 3 days after the alleged issue began, the patient started to feel bad and experienced symptom of ¿sweating a lot¿.The emergency medical services (ems) were reportedly notified for assistance.When ems arrived, the reporter claimed the patient¿s blood glucose measured ¿21 mg/dl¿ on the ems meter.The patient was treated with food and drink and felt better afterwards.At the time of troubleshooting, the cca noted the subject meter was not being used for the first time and there was no indication of misuse to the device.The cca noted the meter would not power on manually when the power button was pressed.The cca noted the test strips associated with the complaint were expired since september 2017.The reporter indicated the meter may have been dropped a couple of times but could not confirm how many times or from what height.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 the alleged issue began.The subject meter could not be ruled out as a cause or contributor to the event.

• 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: 16041351
• MDR Text Key: 306069197
• Report Number: 3009698388-2022-00063
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• 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: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2022
• 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): Required Intervention; Life Threatening
• Patient Sex: Male