MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-14 for FETAL LUNG MATURITY ASSAY manufactured by Abbott Laboratories.
[15179]
Fetal lung maturity assay fails to recover control results within acceptable ranges. The problem appears to be somehow related to the lot nos of standards and controls in use. Mfr's technical service has been contacted numerous time (beginning of 12/94 first call was made) with no immediate action to correct the problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005133 |
| MDR Report Key | 19724 |
| Date Received | 1995-02-14 |
| Date of Report | 1995-02-01 |
| Date Added to Maude | 1995-02-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FETAL LUNG MATURITY ASSAY |
| Product Code | JHG |
| Date Received | 1995-02-14 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19627 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | ABBOTT PARK IL 60064 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-02-14 |