MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-11-12 for ANEUVYSION PRENATAL KIT 35-161075/05J38-50 manufactured by Abbott Molecular.
[20346409]
Months ago, customer performed aneuvysion test (lot number 406681) on amniotic fluid. The aneuvysion result for the pt (normal result) was reported outside of the lab. The child was born with down syndrome, the customer re-tested the same amniotic fluid (which was stored during this time), with other aneuvysion lot number and the result was positive for the trisomy 21. The aneuvysion lot in question (lot number 406681) was tested internally and has performed as expected. The investigation continues. Abbott molecular is in contact with the user facility to determine root cause of this incident. No actions have been taken. There is no evidence of malfunction. No harm to pt (child) was done. This incident is being reported due to the mental anguish anticipated on parents of a child with down syndrome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005248192-2008-00004 |
| MDR Report Key | 1240903 |
| Report Source | 07 |
| Date Received | 2008-11-12 |
| Date of Report | 2008-11-04 |
| Date of Event | 2008-10-06 |
| Date Mfgr Received | 2008-10-16 |
| Date Added to Maude | 2010-05-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MIRNA DIPANO, MANAGER |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617807 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANEUVYSION PRENATAL KIT |
| Generic Name | ANEUVYSION |
| Product Code | MAO |
| Date Received | 2008-11-12 |
| Model Number | NA |
| Catalog Number | 35-161075/05J38-50 |
| Lot Number | 406681 |
| Device Expiration Date | 2008-08-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR |
| Manufacturer Address | DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-12 |