HYPOGUARD 50 1242-00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-10 for HYPOGUARD 50 1242-00 manufactured by Hypoguard.

Event Text Entries

[297420] False positive leukocytes, nitrites and bilirubin on hypoguard diascreen (50) urine dipstick reader/hypoguard reagent strips. Company has resolved nitrite problem and has finally admitted to leukocyte false positives and has come out with new and improved leukocyte reagent strips but will not take bad strips off the market by recalling them, even though they have proven they are defective. After much effort, on rptr's part. Reporter cannot get company to do anything about false positive bilirubins. They called reporter 12/03 and said they could not do anything more even though reporter proved to them reporter is getting 8-9% false positives and they are saying reporter should only have 1-4% false positive. Reporter feels these strips should be improved or be removed from market.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1030513
• MDR Report Key: 501665
• Date Received: 2003-12-10
• Date of Report: 2003-12-03
• Date Added to Maude: 2003-12-19
• 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
• Reporter Occupation: MEDICAL TECHNOLOGIST
• 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 Sequence Number: 1

• Brand Name: HYPOGUARD
• Generic Name: DIASCREEN 50 URINE DIPSTICKS READER
• Product Code: KQO
• Date Received: 2003-12-10
• Model Number: 50
• Catalog Number: 1242-00
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 490457
• Manufacturer: HYPOGUARD
• Manufacturer Address: 7301 OHMS LANE SUITE 200 ELINA MN 55439 US

Device Sequence Number: 2

• Brand Name: HYPOGUARD
• Generic Name: REAGENT STRIPS
• Product Code: CDM
• Date Received: 2003-12-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 490458
• Manufacturer: HYPOGUARD
• Manufacturer Address: 7301 OHMS LANE SUITE 200 ELINA MN 55439 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-12-10