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

Lot Number 5726070

Device Problem Device Handling Problem (3265)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Diaphoresis (2452); Unspecified Eye / Vision Problem (4471); Salivary Hypersecretion (4486)

Event Date 03/29/2024

Event Type  Injury  

Event Description

On april 8, 2024, the lay user/patient contacted lifescan (lfs) united states, alleging that her onetouch ultra2 meter read inaccurately high compared another meter (emergency medical service 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.The patient reported that her husband found her ¿unresponsive, with excessive sweating, mouth full of saliva and eyes fixed¿ around 2:00 am on (b)(6) 2024, and tested her blood glucose with the subject meter and received a reading of ¿120 mg/dl¿.When the emergency medical services (ems) arrived around 10 minutes later, they tested the patient¿s blood glucose and received a reading of ¿below 30 mg/dl¿ on the ems meter and gave her injection of glucagon and an intravenous (iv) infusion.During the call, the patient stated that she manages her diabetes with insulin (lantus, (b)(4) units morning and night; humalog, sliding scale) and that prior to being found unresponsive, she had taken her usual dose of insulin based on blood glucose readings, there had been no change in her diet, and that her blood glucose level had been fine when she went to bed at around 10:00 pm.The patient stated that she was unsure if the subject meter caused her to give herself too much insulin.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca confirmed the test strip vial was intact however noted the test strips had been stored incorrectly.A 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.

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: 19131115
• MDR Text Key: 340447528
• Report Number: 3009698388-2024-00017
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 5726070
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2024
• 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