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

Model Number N/A

Device Problem Failure to Obtain Sample (2533)

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 products 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 54 complaints summarized in this report.The test strip samples received for these complaints all failed testing with the reported issue being confirmed.The investigation into the cause attributed the test strips not filling to a defective hydrophilic portion of engineered top tape (ett) on the test strips.This report is processed under exemption number e2005018.

Event Description

This report summarizes 54 malfunction event(s).A review of the event(s) indicated that the ot select test strips experienced sample not drawn in.These reports were received from various sources.The patients associated with this allegation have no age data and there is no weight data available.Of the reported patients; 21 were male, 15 female & 18 unknown.

• Brand Name: ONETOUCH SELECT 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: 7717521
• MDR Text Key: 114936702
• Report Number: 3008382007-2018-02060
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K072543
• 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

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