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U.S. Department of Health and Human Services

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

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LIFESCAN EUROPE GMBH OT ULTRA 2 METER; GLUCOSE MONITORING SYS/KIT Back to Search Results
Model Number 021-105
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems Fatigue (1849); Dizziness (2194); Confusion/ Disorientation (2553); Presyncope (4410); Increased Appetite (4570)
Event Date 10/31/2020
Event Type  Injury  
Event Description
On (b)(6) 2020, the lay-user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra2 meter read inaccurately erratic and inaccurate compared to her feelings and/or normal readings.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 towards the end of (b)(6) 2020, she began to obtain inaccurate readings always in the morning between 5:30 am to 7:00 am.The patient reported obtaining blood glucose readings of ¿137, 239, 137 and 137 mg/dl¿ with the subject meter, performed more than 20 minutes apart.The patient also reported obtaining what she felt were inaccurate results of ¿239, 137, 143, 215, 174, 126, 139, 120, 91, 137, 116, 110 and 137 mg/dl¿ with the subject meter.The patient stated that she manages her diabetes with oral medication (glimepiride 2 mg) and denied making any changes to her usual diabetes management regimen as a result of the alleged issue.During the call, the patient reported that up until the week prior to contacting lfs, she experienced intermittent episodes between 10:30 am to 11:30 am of feeling ¿faint, feeling like passing out, feeling like she needed something to eat, weak and out of it.¿ the patient reported testing her blood glucose with the subject meter at the onset of symptoms and obtaining a ¿low¿ result (exact reading not provided).In response to the symptoms, the patient claimed she treated herself with food and drink and the symptoms resolved.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca documented that the same approved sample site was used for testing and that the correct testing process was being followed.The cca noted the patient did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged product issue began.The subject meter could not be ruled out as a cause or contributor to the event.
 
Manufacturer Narrative
The lay user/patient¿s meter has been returned and evaluated by lifescan product analysis with the following findings: the meter passed performance testing with no faults found.The reported issue could not be confirmed.In addition, a device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.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.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.
 
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Brand Name
OT ULTRA 2 METER
Type of Device
GLUCOSE MONITORING SYS/KIT
Manufacturer (Section D)
LIFESCAN EUROPE GMBH
gubelstrasse 34
zug 6300
SZ  6300
MDR Report Key11062570
MDR Text Key223386310
Report Number3008382007-2020-04083
Device Sequence Number1
Product Code NBW
UDI-Device Identifier00353885008372
UDI-Public00353885008372
Combination Product (y/n)Y
PMA/PMN Number
K053529
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 12/04/2020
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 Model Number021-105
Device Catalogue Number021-105
Device Lot Number4553053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2021
Initial Date Manufacturer Received 12/04/2020
Initial Date FDA Received12/23/2020
Supplement Dates Manufacturer Received04/12/2021
Supplement Dates FDA Received04/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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