MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2009-12-18 for ABBOTT AXSYM SYSTEM 7A83-01 manufactured by Abbott Manufacturing, Inc..
[16571592]
(b)(4). 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
[16701837]
The account stated that the axsym analyzer has generated a false negative cmv igg result on a patient sample. The initial result was negative at 14 ua/ml. The sample was then tested by the vidas method and the result was positive. The sample was retested on the axsym and the result was positive 22 ua/ml. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[19327775]
(b)(4). Evaluation (there was no device failure). The abbott field service representative (fsr) performed preventive maintenance (pm) on the axsym on (b)(6) 2009. The fsr replaced the tadx lamp and the axsym meia lamp as part of the pm. The fsr found the customer did not have a discrepant result issue with cmv igg patient results. The fsr verified all cmv igg patient and control results were repeatable before and after preventive maintenance was performed. No additional investigation of this issue is needed since the customers issue was resolved with customer interaction and training.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2009-00774 |
| MDR Report Key | 1562041 |
| Report Source | 01,05 |
| Date Received | 2009-12-18 |
| Date of Report | 2009-11-30 |
| Date of Event | 2009-11-27 |
| Date Mfgr Received | 2010-01-26 |
| Device Manufacturer Date | 1999-06-22 |
| Date Added to Maude | 2010-03-01 |
| 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 | NOEMI KONDOS RN, BSN |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 09B9, AP50 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| Manufacturer G1 | ABBOTT MANUFACTURING, INC. |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| 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 | OMI |
| Date Received | 2009-12-18 |
| Catalog Number | 7A83-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-18 |