MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07 report with the FDA on 2009-12-16 for ANEUVYSION DNA PROBE KIT, 30 ASSAY IVD 32-161075 manufactured by Abbott Molecular, Inc..
[1252788]
The customer complaint from the end-user described that a false positive result was generated by the aneuvysion kit. The fish result showed that there was a trisomy 21. However, when the sample was tested by qf-pcr and karyotyping, both results were negative. The end-user, however, reported the fish results as trisomy 21. And the pt under went induced labor. It was reported by the end user that the doctor attempted to stop the induced labor, but the fetus did expire. The end-user did explain that they used a kit that was three months after its expiration date. In the package insert, the "aneuvysion kit is not to be used as a stand alone assay for making clinical decision. " abbott molecular became aware of this event in 2009.
Patient Sequence No: 1, Text Type: D, B5
[8344886]
The event occurred at the hospital in foreign country. The aneuvysion kit, 32-161075, expiration date was december 19, 2008. The lsi 13/21 dna probe's (30-171078, lot 408643) expiration date within the aneuvysion kit was july 31, 2009. The cep 18/x/y dna probe 30-171077, lot 406902 expired on may 8, 2009. Dapi ii counterstain, 30-804941, lot 407954 expired on december 19, 2008. The np-40, 30-804820, lot 406740 expires on june 22, 2010. The 20x scc, 30-805850, lot 406906 expires on september 20, 2012. From the complaint write-up, the reporter had stated that the kit had been expired for three months.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2009-00006 |
| MDR Report Key | 1561318 |
| Report Source | 00,01,07 |
| Date Received | 2009-12-16 |
| Date of Report | 2009-12-16 |
| Date of Event | 2009-11-23 |
| Date Mfgr Received | 2009-11-13 |
| Date Added to Maude | 2009-12-22 |
| 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 | PAULA MARTIN |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617333 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANEUVYSION DNA PROBE KIT, 30 ASSAY IVD |
| Generic Name | NONE |
| Product Code | MAO |
| Date Received | 2009-12-16 |
| Model Number | 32-161075 |
| Lot Number | 4080643 |
| Device Expiration Date | 2008-12-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 EAST TOUHY AVENUE DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2009-12-16 |