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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-25 for * manufactured by *.

Event Text Entries

[353386] Bd colorpak test for cryptosporidium and giardia detection in stool had a 85% false-positive rate. In year 2004 701 tests on stool were performed: 13 were positive by colorpak for cryptosporidium but only 2 could be confirmed by either microscopic exam or immunofluorescent microscopy. There were false-positive tests for four straigh months. All 10 tests positive for giardia by colorpak were confirmed either by microscopy or innunofluorescent microscopy. During approx the same period, a different rapid test -remel- correctly detected only the true-positives and none of the false-positives. Confirmatory testing of all positives was instituted after the last recall of this product last winter. Lot number 0712260 was in use. Lot number 071299 was in use. And 071318 was placed in use lot 071318 appears not to cause false-positives although the observation period is still short, although it is possible that some of the false positives were also caused by use of this lot.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1033093
• MDR Report Key: 553467
• Date Received: 2004-08-26
• Date of Report: 2004-08-25
• Date of Event: 2004-04-01
• Date Added to Maude: 2004-11-08
• 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: *
• Product Code: MHJ
• Date Received: 2004-08-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 543074
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-08-26