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

This report is processed under exemption number (b)(4).Product returns were tested by lfs product analysis.The product failed testing, the issue was confirmed.

Event Description

This report summarizes 2 malfunction event(s).A review of the event(s) indicated that the ot select test strips experienced sample draw issue.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; none were male and 2 female.

• Brand Name: OT 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: michelle karim ; beechwood business park north; inverness, scotland IV2 3-ED ; UK IV2 3ED
• MDR Report Key: 8543978
• MDR Text Key: 142908434
• Report Number: 3008382007-2019-01213
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/01/2019
• Date Manufacturer Received: 04/01/2019
• 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