ICHEM URINE CHEMISTRY STRIPS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-21 for ICHEM URINE CHEMISTRY STRIPS * manufactured by Beckman Coulter.

Event Text Entries

[17129319] Medical technologists working at the off-site laboratories reported a higher-than-usual rate of trace-positive urine leukocyte esterase results. This test is performed as a urine dipstick using ichem strips, and is read using an ichem automated urinalysis reader. Upon hearing this news from the off-site labs, the off-site lab supervisor began calling the dipstick manufacturer to inquire about the cause of the problem. For a week, the off-site lab supervisor tried unsuccessfully to get a satisfactory response from the manufacturer. In the meantime, he tracked the false positives to two particular lots of ichem strips. These strips were put into use at other lab locations on (b)(6), (b)(6), and (b)(6) 2013 respectively. At that time, the decision was made to visually read the leukocyte esterase off the strip because that gives the correct result. This was verified by an experiment in the main lab using both the old and new lots of ichem strips. Therefore, effective (b)(6) 2013, the problem of false positive results was resolved with this work-around and patient results have been reported correctly since.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3431347
• MDR Report Key: 3431347
• Date Received: 2013-10-21
• Date of Report: 2013-10-07
• Date of Event: 2013-08-07
• Report Date: 2013-10-07
• Date Reported to FDA: 2013-10-21
• Date Reported to Mfgr: 2013-10-28
• Date Added to Maude: 2013-10-28
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ICHEM URINE CHEMISTRY STRIPS
• Generic Name: ICHEM URINE CHEMISTRY STRIPS
• Product Code: JJW
• Date Received: 2013-10-21
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 1 DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECKMAN COULTER
• Manufacturer Address: 250 S. KRAEMER BLVD BREA CA 92821 US 92821

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-10-21