MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL ONETOUCH 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

This complaint was 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 the complaint summarized in this report.The test strip samples received for this complaints failed testing with the reported issue being confirmed.The investigation revealed that the test strips were peeling due to a incomplete cut during the slit and vial process.This report is processed under exemption number e2005018.

Event Description

This report summarizes 1 malfunction event.A review of the event indicated that the ot ultra test strips experienced peeling test strip.It is not known if the patient was male or female and there is no age or weight data available.

• Brand Name: ONETOUCH 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: 7717542
• MDR Text Key: 114936672
• Report Number: 3008382007-2018-02067
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K043197
• 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: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 07/01/2018
• Initial Date Manufacturer Received: 07/01/2018
• Initial Date FDA Received: 07/25/2018
• 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