MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-12 for CMV IGM CAPTURE * 720-330 manufactured by Diamedix Corporation.
[486098]
Diamedix changed the antigen (cmv) used in the test kits purchased by the hospital laboratory for performing cmvigm testing. A note was provided in the kit to announce the product change and to say that performance should not be affected. Prior to this change, the laboratory experienced 1 positive cmvigm per every 3 test runs and 1 equivocal per every 5 test runs. After the change, the lab began to see a higher incidence of positive results (1 per run) and equivocal results (2 per run). Tech services at diamedix has been contacted and the raw data has been faxed to them. A partially used test kit was also returned along with some blind samples for them to use with the partially used kit. All samples with positive and equivocal test results are being sent to an off site reference lab for confirmation until this situation is resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 714338 |
| MDR Report Key | 714338 |
| Date Received | 2006-04-12 |
| Date of Report | 2006-04-12 |
| Date of Event | 2006-03-20 |
| Report Date | 2006-04-12 |
| Date Reported to FDA | 2006-04-12 |
| Date Added to Maude | 2006-05-17 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CMV IGM CAPTURE |
| Generic Name | TEST KIT, ANTIGEN |
| Product Code | GQH |
| Date Received | 2006-04-12 |
| Returned To Mfg | 2006-03-20 |
| Model Number | * |
| Catalog Number | 720-330 |
| Lot Number | 90505Z |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 703402 |
| Manufacturer | DIAMEDIX CORPORATION |
| Manufacturer Address | A SUBSIDIARY OF IVAX DIAGNOSTI 2140 NORTH MIAMI AVENUE MIAMI FL 33127 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-04-12 |