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U.S. Department of Health and Human Services

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

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LIFESCAN INC OT ULTRA MINI METER; GLUCOSE MONITORING SYS/KIT Back to Search Results
Lot Number 3425531
Device Problem Device Handling Problem (3265)
Patient Problems Headache (1880); Hypoglycemia (1912); Shaking/Tremors (2515); Cognitive Changes (2551); Confusion/ Disorientation (2553)
Event Date 06/03/2022
Event Type  Injury  
Event Description
On june 14, 2022, the lay-user/patient contacted lifescan (lfs), alleging that their onetouch ultra mini meter read inaccurately high compared to another device (emergency medical services meter).The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began on (b)(6) 2022.The patient reported obtaining blood glucose readings of ¿121 mg/dl¿ with the subject meter and ¿20 mg/dl¿ on the other device, performed more than 30 minutes apart.The patient manages their diabetes with a once weekly non-insulin injection and oral medications.It was not reported if the patient made any changes to their usual diabetes management regimen as a result of the alleged issue.The patient reported developing symptoms of ¿loss of awareness, started to act funny, loss of memory, shaky and headache¿ on (b)(6) 2022.The patient claimed they were treated by the emergency medical services (ems) with iv glucose and food.The patient claimed their blood glucose measured ¿20 mg/dl¿ on the ems device before treatment.The patient also mentioned that their healthcare professional stopped their medication until further review.At the time of troubleshooting, the cca noted that an approved sample site was used for testing.The cca noted that the patient was testing with test strips that were expired since 2014.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 inaccuracy issue occurred.The subject meter could not be ruled out as a cause or contributor to the event.
 
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Brand Name
OT ULTRA MINI METER
Type of Device
GLUCOSE MONITORING SYS/KIT
Manufacturer (Section D)
LIFESCAN INC
20 valley stream parkway
malvern PA 19355
MDR Report Key14881531
MDR Text Key295124594
Report Number2939301-2022-03057
Device Sequence Number1
Product Code NBW
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 06/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Lot Number3425531
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date06/14/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/30/2022
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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