QUANTI MATRIX DROPPER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-14 for QUANTI MATRIX DROPPER manufactured by Crunin Diagnostics Ltd..

Event Text Entries

[2124871] Package inserts of each product do not agree on proper procedure. These products are intended to be used together, however, mfrs do not agree on instructions for use. This creates confusion on correct testing procedures inside /outside lab when trying to establish best practice. There have been no safety or integrity issues. This remains a controlled test, but is not user friendly due to inconsistencies in mfr instructions for use. One product states to dip in specimen for 1-2 seconds, the other directs the user to let the drop touch the strip.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5021351
• MDR Report Key: 2166686
• Date Received: 2011-07-14
• Date of Report: 2011-07-14
• Date of Event: 2011-07-01
• Date Added to Maude: 2011-07-21
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: QUANTI MATRIX DROPPER
• Generic Name: URINALYSIS DIPSTICK
• Product Code: KQO
• Date Received: 2011-07-14
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CRUNIN DIAGNOSTICS LTD.
• Manufacturer Address: NANGOR RD., 56/66 HUME CTR. PARK WEST INDUSTRIAL ESTATE DUBLIN 12 EI

Device Sequence Number: 2

• Brand Name: MULTISTIX 1056
• Generic Name: REAGENT STRIPS
• Product Code: MSY
• Date Received: 2011-07-14
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
• Manufacturer Address: 51 VALLEY STREAM PKWY. MALVERN PA 19355 US 19355

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-07-14