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

Device Problem Crack (1135)

Patient Problem Fainting (1847)

Event Date 06/18/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) usa, alleging that the casing of her onetouch delica lancing device was cracked and/or broken.The complaint was classified based on information obtained from the customer service representative (csr) documentation.The patient reported that the alleged issue began at an unspecified time on (b)(6) 2017.The patient manages her diabetes with self-adjusted insulin (unspecified type and dose) and she denied making any changes to her usual diabetes management regimen in response to the alleged issue.The patient reported that at an unspecified time on (b)(6) 2017, after the alleged issue had occurred, she ¿passed out¿ and had to be taken to the emergency room (e.R).The patient advised that upon arrival at the e.R, he blood glucose was measured at ¿27 mg/dl¿ on the e.R device (brand not reported) and that she was subsequently treated with a glucagon injection by a healthcare professional (hcp).At the time of troubleshooting, the csr noted that there was no apparent misuse of the lancing device and that it had been in use for approximately 1 month prior to the alleged issue occurring.The csr established that the correct lancets were being used and noted that the lancet gauge was 33g.The subject product was requested back for investigation and a replacement was sent to the patient.This complaint is being reported because the patient claims she was unable to test her blood glucose due to the reported issue and reportedly developed symptoms suggestive of a serious injury adverse event after the alleged meter issue began.

Manufacturer Narrative

The lay user/patients lancing device has been returned and evaluated by lifescan product analysis with the following findings: the lancing device passed all testing with no faults found.The reported issue could not be confirmed.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• 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: 6727334
• MDR Text Key: 80492304
• Report Number: 3008382007-2017-21935
• 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: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/18/2017
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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