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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH UNKNOWN METER; GLUCOSE MONITORING SYS/KIT

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LIFESCAN EUROPE GMBH UNKNOWN METER; GLUCOSE MONITORING SYS/KIT Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Fall (1848); Pain (1994); Dizziness (2194)
Event Date 11/05/2021
Event Type  Injury  
Event Description
On (b)(6) 2021, the lay user/patient made a post on social media alleging that her unspecified onetouch meter read inaccurate.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that at an unspecified date and time, she obtained an alleged inaccurate blood glucose reading of ¿22.7 mmol/l¿ with the subject meter after eating half of a cheese sandwich on brown bread and skim milk.It was not reported if the patient takes any medication to manage her diabetes or if she made any changes to her usual diabetes management regimen as a result of the alleged issue.However, the patient reported that an unspecified time after the alleged issue occurred she felt ¿dizzy, fell down and hurt her head.¿ it was not reported if the patient received any treatment due to the alleged issue.No further information has been obtained from the patient.Troubleshooting was unable to be performed.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.
 
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Brand Name
UNKNOWN METER
Type of Device
GLUCOSE MONITORING SYS/KIT
Manufacturer (Section D)
LIFESCAN EUROPE GMBH
gubelstrasse 34
zug 6300
SZ  6300
MDR Report Key12783662
MDR Text Key281855594
Report Number2939301-2021-02982
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/09/2021
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
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date11/05/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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