MAUDE Adverse Event Report: STAT MEDICAL DEVICES, INC. STAT QWIK-LET LITE LANCING DEVICE

Model Number QLL-L02

Device Problems Failure to Fire (2610); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2012

Event Type  malfunction  

Manufacturer Narrative

The original complaint, (b)(4), for this product return was closed on 08/29/2012.This new complaint (b)(4) was opened after consultation with the (b)(4) on the re-assessment of the mdr submission for this returned product.

Event Description

Customer called to say that he just received one of our lancing devices from their mail order group (b)(4) and the device does not fire when pulling the arming mechanism out.Worked with customer over the phone to attempt to get device armed and fired, but could not.Customer could however push a lancet into the "engine" and force the mechanism back, which then allowed the device to be fired with the trigger button.Stat medical received and analyzed the qll device.It was determined that the actuator bottom was glued to the bottom housing.The device was either not test fired, or such an extensive amount of glue was used that the glue was used that the glue was still wet when it was fired, thus allowing the device to operate at that time.

• Brand Name: STAT QWIK-LET LITE LANCING DEVICE
• Manufacturer (Section D): STAT MEDICAL DEVICES, INC.; north miami FL
• Manufacturer Contact: 2056 ne 153 st.; north miami, FL 33181 ; 3059450011
• MDR Report Key: 5021525
• MDR Text Key: 24797738
• Report Number: 1058955-2015-00017
• Device Sequence Number: 1
• Product Code: FMK
• 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
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: QLL-L02
• Device Catalogue Number: SM-QLL-L02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2012
• 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): Other
• Patient Age: 60 YR
• Patient Weight: 86