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U.S. Department of Health and Human Services

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

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LIFESCAN INC OT ULTRA 2 METER; GLUCOSE MONITORING SYS/KIT Back to Search Results
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 (b)(6), 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, 100 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.
 
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Brand Name
OT ULTRA 2 METER
Type of Device
GLUCOSE MONITORING SYS/KIT
Manufacturer (Section D)
LIFESCAN INC
20 valley stream parkway
malvern PA 19355
MDR Report Key19131151
MDR Text Key340449259
Report Number2939301-2024-00034
Device Sequence Number1
Product Code NBW
UDI-Device Identifier00353885008372
UDI-Public00353885008372
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
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 Received04/18/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Lot Number5726070
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date04/08/2024
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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