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

Device Problem Defective Component (2292)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

On (b)(6) 2020, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch delica lancing device cap was loose/falls off and that the device was not working.The complaint was classified based on the customer care agent (cca) documentation and further information obtained when medical surveillance reviewed the call recording, since the patient was unable to be reached by phone for additional information.It was not reported when the alleged lancing device issues began.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 issues however she indicated she was unable to check her blood glucose.It was not reported if the patient developed any symptoms due to the alleged issues.However, the patient reported that her blood glucose had risen to ¿500 to 600 mg/dl¿ after the alleged issues began.At the time of troubleshooting, the cca noted the product was not being used for the first time and there was no indication of misuse of the device.The cca determined the correct lancets were being used for testing.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed signs suggestive of a serious injury adverse event after the alleged lancing device issues began.The subject device lancing could not be ruled out as a cause or contributor to the event.

• Brand Name: OT DELICA LANCING DEVICE
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; CH 6300
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; GB IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; GB IV2 3ED ; 1463383679
• MDR Report Key: 10226504
• MDR Text Key: 197607048
• Report Number: 3008382007-2020-03954
• 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: 06/08/2020

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
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 07/02/2020
• 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