ABBOTT AXSYM AMPHETAMINE/METHAMPHETAMINE 2 REAGENT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-03 for ABBOTT AXSYM AMPHETAMINE/METHAMPHETAMINE 2 REAGENT * manufactured by Abbott Laboratories.

Event Text Entries

[14869620] On feb 2, 2005, we rec'd a call from a physician questioning our postive amphetamine drug screen report. We sent the sample for confirmation and it came back negative. We checked several other pts and we had reported positive but the confirmations came back negative. A second physician called questioning our results and again, we found we had misreported the amphetamine. We contacted the mfr and were told there had been a letter sent in 09/2004 that addressed the changes in the reagent's specificity. There was absolutely nothing in print on the package insert that the cutoff values would be affected by this change in precision. The date on the package insert was 08/04. The 09/04 letter showed how the new antibody lot would change and cause some pts who were negative to be called positive. This letter was only sent to customers who actually called abbott and had an issue. It was not sent to everyone using their amphetamine assay. We checked with another hosp and found they had been having qc issues in jan and were sent the letter then. We obtained the letter via fax from that hosp in 02/05. We never rec'd this letter from abbott. During this time, we never had an issue with controls and the only way we were made aware of this problem was by the physician complaints. We now verifty all our positive abbott amphetamines with surestep and also send out for gc/ms. If the samhsa cutoff we use of 1000 ng/ml is used, some of these pts are way over the cutoff and yet the gc/ms shows negative.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1035644
• MDR Report Key: 753658
• Date Received: 2005-06-03
• Date of Report: 2005-06-03
• Date of Event: 2005-02-02
• Date Added to Maude: 2006-08-25
• 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: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ABBOTT AXSYM AMPHETAMINE/METHAMPHETAMINE 2 REAGENT
• Generic Name: REAGENT
• Product Code: DKZ
• Date Received: 2005-06-03
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 741466
• Manufacturer: ABBOTT LABORATORIES
• Manufacturer Address: * ABBOTT PARK IL 60064 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2005-06-03