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 NumberMW1021124
MDR Report Key316922
Date Received2001-02-19
Date of Report2001-02-19
Date of Event2001-01-18
Date Added to Maude2001-02-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameACETEST-BAYER
Generic NameLAB RESULT DISCREPANCE
Product CodeLAS
Date Received2001-02-19
Model Number*
Catalog Number*
Lot Number9B03FA
ID Number*
Device Expiration Date2004-02-12
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key306461
ManufacturerBAYER CORP.
Manufacturer Address430 SOUTH BEIGER MISHAWAKA IN 46544 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2001-02-19

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