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

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.

• 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 Key: 12783662
• MDR Text Key: 281855594
• Report Number: 2939301-2021-02982
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• 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 Date: 11/05/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening