ACETEST-BAYER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-02-19 for ACETEST-BAYER * manufactured by Bayer Corp..

Event Text Entries

[235483] Lab result discrepance, method to method. Facts: a pt was seen in the emergency room for ingestion of toxic substances. Hosp's laboratory performed a qualitative acetone and sent the same specimen out for a quantitative acetone. Laboratory performed the test using, bayer: acetest reagent tablets, lot 9b03f-a. The test performed at laboratory was repeatedly negative. The specimen was sent to quest diagnostic for quantitative acetone. The result from quest was returned as 842 mg/l two days later. Bayer rep investigated the product and had opportunitiy to test both the lot involved and the pt specimen. Bayer found the product is sensitive to acetone and would show a positive result at 270 mg/l and would show a strong positve at 570 mg/l. Bayer's conclusion: no problem with the bayer product. Quest rep was contacted and has reaffirmed result integrity. Quest believed their "gc" reporting a high level (toxic) acetone, with a pt specimen migration of 2. 39 with acetone standard migration of 2. 40 and control migration of 2. 39 is confirmation. Conclusion: no problem with the result. The pt acetone level is 842 mg/l. As of 02/2001, the discrepant results are unexplained. Both bayer the mfr of acetest and quest diagnostics claim their product/result are not defective.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1021124
• MDR Report Key: 316922
• Date Received: 2001-02-19
• Date of Report: 2001-02-19
• Date of Event: 2001-01-18
• Date Added to Maude: 2001-02-26
• 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: 0
• 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 Details

• Brand Name: ACETEST-BAYER
• Generic Name: LAB RESULT DISCREPANCE
• Product Code: LAS
• Date Received: 2001-02-19
• Model Number: *
• Catalog Number: *
• Lot Number: 9B03FA
• ID Number: *
• Device Expiration Date: 2004-02-12
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 306461
• Manufacturer: BAYER CORP.
• Manufacturer Address: 430 SOUTH BEIGER MISHAWAKA IN 46544 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-02-19