MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-05-12 for ANEYVYSION MULTICOLOR DNA PROBE KIT 05J38-30 manufactured by Abbott Molecular, Inc..
[2510267]
Product name: aneuvysion multicolor dna probe kit. Intended use: the aneuvysion (vysis cep 18, x, y-alpha satellite, ls1 13 and 21) multicolor probe panel is intended to use cep 18/x/y probe to detect alpha satellite sequences in the centromere regions of chromosomes 18, x, and y, and ls1 13/21 probe to detect the 13q 14 region and the 21q22, 13 to 21q22. 2 region. The aneuvysion kit is indicated for identifying and enumerating chromosomes 13, 18, 21, x, and y via fluorescence in situ hybridization (fish) in metaphase cells and interphase nuclei obtained from amniotic fluid in subjects with presumed high risk pregnancies. It is not intended to used as a stand alone assay for making clinical decisions. Fish results are intended to be used as an aid in the diagnosis of numerical abnormalities of chromosomes 13, 18, 21, x and/or y in conjunction with other info currently used in prenatal diagnosis, consistent with professional standards of practice. This device is intended for use only with amniocyte cells; it is not intended for and has not been validated for use with other test matrices. This fish assay will not detect the presence of structural chromosome abnormalities that can also result in birth defects. This fish assay will be performed in cytogenetics laboratories. A customer in germany stated that false positive results were reported with the aneuvysion multicolor dna probe kit. Three cep16 signals were detected and reported as trisomy 16, but after abortion fetus was healthy.
Patient Sequence No: 1, Text Type: D, B5
[9572369]
Abbott molecular has contacted the customer and requested more info regarding this event. A f/u report will be submitted to the fda after more info is received from the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2011-00005 |
| MDR Report Key | 2371755 |
| Report Source | 07 |
| Date Received | 2011-05-12 |
| Date of Report | 2011-05-12 |
| Date of Event | 2011-05-06 |
| Date Mfgr Received | 2011-05-06 |
| Device Manufacturer Date | 2010-06-25 |
| Date Added to Maude | 2011-12-15 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. DIMITRIS DEMIRTZOGLOU |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617975 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANEYVYSION MULTICOLOR DNA PROBE KIT |
| Generic Name | DNA-PROBE, HUMAN CHROMOSOME, PRODUCT CODE: MAO |
| Product Code | MAO |
| Date Received | 2011-05-12 |
| Catalog Number | 05J38-30 |
| Lot Number | 425879 |
| Device Expiration Date | 2011-05-14 |
| 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 AVE. DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2011-05-12 |