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

Device Problem Insufficient Information (3190)

Patient Problems Dysphasia (2195); Malaise (2359); Syncope/Fainting (4411)

Event Date 08/25/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, the patient/lay user contacted lifescan (lfs) usa alleging that his onetouch verio meter does not turn on.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and on additional information obtained after medical surveillance specialist reviewed the call recording.The patient alleged that the issue with the subject meter started on (b)(6) 2023, at approximately 6:00 am when he woke up ¿feeling unwell¿.The patient claimed that he tried testing his blood glucose, but the subject meter did not turn on.The patient manages his diabetes with unspecified insulin (insulin pen) and did not specify whether he made any changes in response to the alleged issue.The patient reported that he started feeling worse during the day until he ¿fell out¿ and the ambulance went to get him.The patient felt ¿incoherent¿ after this happened.The patient explained that in the hospital a blood glucose reading of ¿270 mg/dl¿ was recorded on a hospital meter and he was treated by hcp¿s with a combination of medication via iv to get his sugar down.During the call with lfs, the patient was in the hospital and did not have the subject device available to go through troubleshooting.A replacement meter was sent to the patient.This complaint is being reported because the patient claims he was unable to test his blood glucose due to the reported issue and reportedly developed symptoms suggestive of a serious injury adverse event after the alleged meter issue began.

• 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: 17761323
• MDR Text Key: 323576494
• Report Number: 2939301-2023-00067
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• 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: 08/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Sex: Male