MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-02-21 for ABBOTT AXSYM SYSTEM 7A83-01 manufactured by Abbott Manufacturing, Inc..
[18332630]
The customer observed axsym imprecision while testing pt samples. A sample test tested axsym toxoplasma igm negative (0. 36 index value) in 2005 retested toxoplasma igm postive at another facility using beckman access method. The same pt was redrawn in 02/2005 and the axsym toxoplasma igm result was positive (2. 75 index value). No impact to pt managemdent was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2005-00005 |
| MDR Report Key | 578096 |
| Report Source | 06 |
| Date Received | 2005-02-21 |
| Date of Report | 2005-02-17 |
| Date of Event | 2005-01-13 |
| Date Mfgr Received | 2005-02-03 |
| Device Manufacturer Date | 1999-11-01 |
| Date Added to Maude | 2005-03-07 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. DAVID SPINDELL, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479351869 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT AXSYM SYSTEM |
| Generic Name | AUTOMATED IMMUNAOSSAY ANALYZER |
| Product Code | JHE |
| Date Received | 2005-02-21 |
| Model Number | NA |
| Catalog Number | 7A83-01 |
| Lot Number | NA |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 567945 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 1921 HURD DR. IRVING TX 75038 US |
| Baseline Brand Name | ABBOTT AXSYM SYSTEM |
| Baseline Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Baseline Model No | NA |
| Baseline Catalog No | 7A83-01 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-02-21 |