MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2008-02-18 for AXSYM DRUGS OF ABUSE TOXICOLOGY ASSAY DISK 3D54-08 manufactured by Abbott Laboratories.
[795281]
The customer stated a vrtx 0002 in task 40 error occurred when an amphetamine assay was about to result on the axsym analyzer. The customer had adjusted the assay cutoff value to 300 prior to processing the patient sample. The customer received the customer communication letter instructing users not to edit the cutoff to avoid the error, but forgot about it. Power was cycled, the amphetamine assay was deleted and reinstalled on the axsym, and the customer recalibrated and added amphetamine quality controls, means, and ranges. The issue was resolved. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[8092402]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2008-00035 |
| MDR Report Key | 999086 |
| Report Source | 04,05 |
| Date Received | 2008-02-18 |
| Date of Report | 2008-01-30 |
| Date of Event | 2008-01-30 |
| Date Mfgr Received | 2008-01-30 |
| Date Added to Maude | 2008-07-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUDARSHAN HEBBAR, MD |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646112 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646112 |
| Manufacturer Phone | 8479379677 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 1415939-2/01/08-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXSYM DRUGS OF ABUSE TOXICOLOGY ASSAY DISK |
| Generic Name | AMPHETAMINE TEST SYSTEM |
| Product Code | MGX |
| Date Received | 2008-02-18 |
| Model Number | NA |
| Catalog Number | 3D54-08 |
| Lot Number | NA |
| ID Number | VERSION 8.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 998667 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-18 |