MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2008-02-06 for AXSYM DRUGS OF ABUSE TOXICOLOGY ASSAY DISK 3D54-08 manufactured by Abbott Laboratories.
[804710]
The customer stated that vrtx error 0002 in task 40 was reoccurring on the axsym analyzer during quality control and pt runs of the amphetamine assay. The drugs of abuse (doa) disk version 8. 0 was installed successfully that morning and the cutoff values were altered. The customer was instructed to cycle power, delete the amphetamine assay, reinstall it, and not alter the cutoff parameters. The prod correction letter was sent to the customer to explain this procedure. No impact to pt mgmt was reported.
Patient Sequence No: 1, Text Type: D, B5
[7947257]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2008-00014 |
| MDR Report Key | 991854 |
| Report Source | 04,05 |
| Date Received | 2008-02-06 |
| Date of Report | 2008-02-01 |
| Date of Event | 2008-01-16 |
| Date Mfgr Received | 2008-02-01 |
| Date Added to Maude | 2008-09-29 |
| 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, D-3MQC, AP6B |
| Manufacturer Street | 100 ABBOTT PARK RD. |
| 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 | DKZ |
| Date Received | 2008-02-06 |
| 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 | 991664 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-06 |