MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2009-10-12 for ABBOTT AXSYM SYSTEM 7A83-01 manufactured by Abbott Manufacturing, Inc..
[1173543]
The account stated that the axsym analyzer has generated a false negative cmv igm result on a patient sample. The index value was negative between 0. 268-0. 356. The sample was then tested by the vidas method, and the result was positive at 1. 85. The cmv igg result for this patient was also positive. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[8283227]
(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
[8406138]
(b)(4). An fsr found the solution #4 pump was dispensing about 50% of expected volume. The fsr replaced the pump. The fsr found the processing probe was dripping during a flush, and the processing probe failed a probe calibration. The fsr replaced the processing side syringe valve. The fsr ran a successful processing probe calibration, and a control run to verify the analyzer performance. The complaint text notes the probable causes of the erratic results issue was buffer pump and syringe valve failures. The fsr documented that the buffer pump and syringe valve were replaced as hard failures and were worn out from normal use. A service history review found no additional complaints have been documented for axsym (b)(6) since the fsr serviced the axsym, and replaced the buffer pump and syringe valve. A level 3 investigation was opened on (b)(6), 2001 to reduce the occurrence of inconsistent results on the axsym analyzer. The investigation determined inconsistent results were generated if the operator failed to follow assay specific package inserts and/or the abbott axsym system operations manual concerning sample handling, loading reagent packs, probe crash recovery, weekly maintenance and the loading of bulk solutions. As part of level 3 investigation, a product information letter (pi (b)(6) 2001) was issued to reinforce the importance of following instructions provided in the abbott axsym system operations manual, addendums and assay-specific package inserts in order to ensure optimum performance of the axsym system. An abbott metrics report for the axsym analyzer was reviewed and no adverse trends were found to have been identified for cmv igm assay erratic results generation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2009-00501 |
| MDR Report Key | 1500623 |
| Report Source | 01,05 |
| Date Received | 2009-10-12 |
| Date of Report | 2009-09-21 |
| Date of Event | 2009-09-15 |
| Date Mfgr Received | 2009-10-19 |
| Device Manufacturer Date | 1995-04-28 |
| Date Added to Maude | 2010-03-09 |
| 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 | 2009-10-12 |
| 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 | 2009-10-12 |