MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT ULTRA TEST STRIPS; GLUCOSE MONITORING SYS/KIT

Model Number N/A

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

These complaints were initially ruled out at the time of complaint receipt as during customer services troubleshooting, there was no indication to reasonably suggest that the product malfunctioned and there was also no allegation of any adverse events as a result of the reported issues.Complaints relating to the reported product(s) were evaluated.It was concluded that the number of complaints for the product(s) did not breach thresholds indicative of a systemic quality or risk issue.Lifescan (lfs) received and further evaluated product returns for theses complaints.The test strip samples received failed testing, the reported issue was confirmed confirmed.The investigation revealed that the test strips were damaged during the slit and vial process.This report is processed under exemption number e2005018.

Event Description

This report summarizes 2 malfunction events.A review of the events indicated that the ot ultra test strips experienced a peeling test strip issue.These reports were received from various sources.It is not known if the patients associated with this allegation were male or female and there is no age or weight data available.

• Brand Name: OT ULTRA TEST STRIPS
• 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 SCOTLAND; beechwood business park north; inverness, scotland IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: goncalo sousa ; beechwood business park north; inverness, scotland IV2 3-ED ; UK IV2 3ED
• MDR Report Key: 7999662
• MDR Text Key: 124982020
• Report Number: 3008382007-2018-02835
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062195
• 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: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/01/2018
• Date Manufacturer Received: 10/01/2018
• 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