MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT DELICA LANCING DEVICE; GLUCOSE MONITORING SYS/KIT

Device Problem Defective Component (2292)

Patient Problems Anxiety (2328); Sweating (2444); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

On (b)(6) 2018, the lay user/patient contacted lifescan usa alleging an issue with their onetouch delica lancing device.The complaint was classified based on the customer care advocate (cca) documentation.The patient reported that the lancing device issue occurred between 6 and 7pm on (b)(6) 2018.The patient manages their diabetes with an unspecified dosage of novalog insulin per day and did not make any changes to their usual diabetes management regimen as a result of the alleged product issue.The patient reported that an hour after the alleged product issue occurred they developed symptoms of ¿stress, shaking, sweating and anxiety¿.In response to this the patient self-treated by consuming water and had a rest.At the time of troubleshooting, the cca reviewed the patient¿s technique for collecting a sample and noted that the incorrect lancets were being used.The patient¿s products were replaced.This complaint is being reported because the patient claims they were unable to test their blood glucose due to the reported issue and reportedly developed symptoms suggestive of a serious injury adverse event after the alleged product issue began.

• Brand Name: OT DELICA LANCING DEVICE
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: m. chiusano / y. wandolski ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7649447
• MDR Text Key: 112705367
• Report Number: 3008382007-2018-01839
• 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: Other Caregivers
• Type of Report: Initial
• Report Date: 06/22/2018

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
• Other Device ID Number: 1-U93NQP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/22/2018
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 06/29/2018
• 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
• Patient Outcome(s): Life Threatening