MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2005-06-21 for ABBOTT AXSYM SYSTEM 7A83-01 manufactured by Abbott Manufacturing, Inc..
[16825476]
The customer states that in 2005, one pt generated an axsym to xoplasmosis igm assay index result of 1. 04 (reactive). The axsym toxoplasmosis igg assay result for this pt was reactive at 19 iu/ml. A new sample was drawn 16 days later, and generated a reactive axsym toxo igm assay result of 0. 94. The samples were sent to a follow-up ctr lab for testing and generated non-reactive results. The most recent sample was also sent to another testing laboratory and generated a non-reactive result for toxo igm. Controls were within specifications on all runs. A review of the axsym's message history log found a number of hardware errors occurring around the same time as the testing of both samples. A field service technical executive (te) was sent to the customer site. There is no impact to pt management reported.
Patient Sequence No: 1, Text Type: D, B5
[17052557]
The field service technical executive (te) was dispatched to resolve the hardware issues and to provide customer training. The te replaced the mup pump (#3) as there was crystallization on the pump. Afterwards, the pump and volume checks as well as the mup/background checks were within specification. Both probes were calibrated, the tubings were checked and no bubbles were found. Controls were run and were within specifications and no further issues were documented. Daily and weekly maintenance requires the operator to check for dirt/damage to the probe and to flush and prime the pumps and syringes. It was also learned the pt samples are not being centrifuged per package insert instructions. The most probable cause for the inconsistent results was the pump and specimen integrity. The actual cause could not be determined with the available information. This issue is covered in the laveling of the system. Multiple probable causes and corrective actions are listed for an inconsistent result. In conclusion, no systemic issues were identified indicating that the product is performing outside of labeling claims. There was no deficiency found concerning the axsym system that would suggest that the use of this product would cause some type of adverse health consequences or that the product is performing contrary to intended use or label claims. This is a final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2005-00028 |
| MDR Report Key | 729800 |
| Report Source | 01,05,06 |
| Date Received | 2005-06-21 |
| Date of Report | 2005-06-21 |
| Date of Event | 2005-05-16 |
| Date Mfgr Received | 2005-06-03 |
| Device Manufacturer Date | 2000-10-01 |
| Date Added to Maude | 2006-06-29 |
| 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 | 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 IMMUNOASSAY ANALYZER |
| Product Code | GMN |
| Date Received | 2005-06-21 |
| Model Number | NA |
| Catalog Number | 7A83-01 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 718096 |
| 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 | 2005-06-21 |