MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-06-27 for MONO-PLUS QUALITATIVE ASSAY NI manufactured by Princeton Biomedical.
[18476397]
All of the tests from lot 222b21 of the mono-plus qualitative assay for infectious mononucleosis have been giving false positive test results on tests run by a hosp lab. Sixteen pt tests were done and all were positive. It appears that all 16 results were false positives. Also, a sample of blood from someone, known with certainty to not have infectious mononucleosis, was tried and tested positive. The hosp's dir of quality and risk mgmt called the distributor of the tests, as identified on the label and they reported that they had received 3 to 4 other complaints about lot 222b21. On 07/2002, the distributor was called for add'l info. Mgr of compliance confirmed that they had received 3 to 4 other complaints. The distributor is having their r and d dept test reserve samples, they had kept. They have not finished their investigation or determined a cause of the problem. The firm considered putting a stop sale on the product but had none left. No recall has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003324 |
| MDR Report Key | 411849 |
| Date Received | 2002-06-27 |
| Date of Report | 2002-06-27 |
| Date of Event | 2002-04-15 |
| Date Added to Maude | 2002-08-22 |
| 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 | RISK MANAGER |
| 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 | MONO-PLUS QUALITATIVE ASSAY |
| Generic Name | ASSAY FOR MONONUCLEOSIS |
| Product Code | KTN |
| Date Received | 2002-06-27 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | 222B21 |
| ID Number | NI |
| Device Expiration Date | 2003-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 400868 |
| Manufacturer | PRINCETON BIOMEDICAL |
| Manufacturer Address | * PRINCETON NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-06-27 |