MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH ULTRASOFT LANCING DEVICE; GLUCOSE MONITORING SYS/KIT

Device Problem Defective Component (2292)

Patient Problems Weakness (2145); Sweating (2444)

Event Type  Injury  

Event Description

On (b)(6) 2018, the patient contacted lifescan (lfs) usa alleging her husband¿s lancing device was broken.The cap was loose and would not screw on.The complaint was classified based on customer service representative (csr) documentation, and further information obtained when medical surveillance specialist reviewed the call.The reporter stated that the issue with the lancing device began 6-8 weeks prior to contacting lfs.She reported that her husband manages his diabetes with a combination of medication, including insulin (self-adjusted) and actos 2.5 mg once a day.The reporter stated that because her husband was unable to test, at times he was unsure what was the correct diabetes medication to administer, and therefor did not administer his usual insulin.The reporter stated that after the issue began, approximately 10 days prior to her contacting lfs, her husband developed symptoms of ¿both excessive sweating and feeling weak, at different times¿.In response to the symptoms his wife reported that she treated him with insulin and called an ambulance.The reporter stated that when the ambulance arrived his readings (unknown result) were back to normal.During troubleshooting the csr noted that there was no misuse of the product and the correct cap was being used.The issue was not resolved with troubleshooting.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after the alleged product issue began.There is insufficient information to rule out the contribution of the device to the event.

• Brand Name: ULTRASOFT LANCING DEVICE
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: oyinkan donaldson ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8234876
• MDR Text Key: 132763459
• Report Number: 3008382007-2019-00117
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/29/2018

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: 12/29/2018
• Initial Date Manufacturer Received: 12/29/2018
• Initial Date FDA Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1