MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-04 for MONOLERT manufactured by Meridian Diagnostics, Inc..
[5684]
According to an article published by rptr, 38 children (ages 18 months to 17 years) who were diagnosed with acute im using the test during the period 10/92 to 8/93. Eighty-three percent of these children had no evidence of epstein-barr virus infection on subsequent investigation. The false positive results of the test could not be explained on the basis of elevated antibody titers to either cytomegalovirus or borrelia burgdorferi. Conclusion by the rptr is that this is a poor screening test and is of little apparent value as a diagnostic test for acute epstein-barr virus infection in pediatric pts. (*)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1004647 |
| MDR Report Key | 18708 |
| Date Received | 1995-01-04 |
| Date Added to Maude | 1995-01-05 |
| 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 |
| 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 | MONOLERT |
| Generic Name | MONONUCLEOSIS TEST ELISA |
| Product Code | LJN |
| Date Received | 1995-01-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 18636 |
| Manufacturer | MERIDIAN DIAGNOSTICS, INC. |
| Manufacturer Address | CINCINNATI OH 45244 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-01-04 |