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 Problem Headache (1880)

Event Date 03/25/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa, alleging a depth adjustor issue with her onetouch delica lancing device.The complaint was classified based on the customer care advocate (cca) documentation and additional information obtained following a review of the call by a medical surveillance specialist.The patient reported that the problem with the lancing device began one morning, around (b)(6) 2018, when it ¿got broken¿.The patient manages her diabetes with oral medication of metformin and routinely checks her blood glucose levels four times per day.She stated that as a result of the alleged issue, she could not adjust the depth adjustor on the lancing device and she was unable to test her blood glucose levels.She reported that she had continued with her usual dose of metformin following the start of the alleged issue.She stated that at approximately 5am on (b)(6) 2018, she woke up with a ¿headache¿.She stated that she lay down with a cold towel, administered ibuprofen and consumed some peanut butter crackers and orange juice around 6:30am; she indicated that she ¿didn't know what was going on¿ with her sugars.She stated that her headache persisted for five days, and on the afternoon of (b)(6) 2018, she went to the urgent care clinic where she was referred to the emergency room (er).She stated that while at the er, a blood glucose result of around ¿300+mg/dl¿ was obtained on an unknown hospital meter and she received treatment of iv fluids.The patient had ¿no idea¿ about the type of ivs she was treated with.The patient reported that she remained in the er for 6-7 hours and, on discharge, was advised to contact her doctor for follow-up.She stated that her doctor considered her blood glucose levels to be ¿not in control¿ and she had ¿an injectable once a week¿ added to her prescription and her metformin was increased from 500mg to 1000mg per day.At the time of troubleshooting, the patient confirmed that she had been using the lancing device for about 4 years.Based on the information provided, there was no misuse of the product.The cca confirmed that the patient was using the correct 33g lancets.The cca reviewed the patient¿s technique to collect the blood sample, but the issue remained unresolved.A replacement lancing device was sent to the patient.This complaint is being reported because the patient reportedly received hcp treatment/medical intervention for an acute blood glucose excursion after her lancing device was broken and she was unable to check her blood glucose levels.

• 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: mariano chiusano ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7424397
• MDR Text Key: 105235782
• Report Number: 3008382007-2018-01087
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• 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: 04/01/2018

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: 04/01/2018
• Initial Date Manufacturer Received: 04/01/2018
• Initial Date FDA Received: 04/12/2018
• 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; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 82