MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-06-06 for HYBRID CAPTURE SYSTEM CMV DNA TEST VERSION 2.0 4403-2003 manufactured by Digene Corporation.
[369802]
Clinical laboratory reported an essay validation failure. The report indicated that all assay values, including positive controls and targets, were very low. Returned product was evaluated and it was determined that some of the tubes were not coated with antibody.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2004-00001 |
| MDR Report Key | 590926 |
| Report Source | 06 |
| Date Received | 2004-06-06 |
| Date of Report | 2004-05-04 |
| Date Mfgr Received | 2004-05-04 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2005-04-14 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | DONNA SOWERS |
| Manufacturer Street | 1201 CLOPPER ROAD |
| Manufacturer City | GAITHERSBURG MD 20878 |
| Manufacturer Country | US |
| Manufacturer Postal | 20878 |
| Manufacturer Phone | 3019447000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1122376-06/03/04-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYBRID CAPTURE SYSTEM CMV DNA TEST VERSION 2.0 |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | LJO |
| Date Received | 2004-06-06 |
| Returned To Mfg | 2004-05-12 |
| Model Number | NA |
| Catalog Number | 4403-2003 |
| Lot Number | 6234 |
| ID Number | NA |
| Device Expiration Date | 2004-10-20 |
| Operator | OTHER |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 580783 |
| Manufacturer | DIGENE CORPORATION |
| Manufacturer Address | * GAITHERSBURG MD * US |
| Baseline Brand Name | HYBRID CAPTURE SYSTEM CMV DNA TEST (VERSION 2.0) |
| Baseline Generic Name | HCS CMV DNA TEST |
| Baseline Model No | NA |
| Baseline Catalog No | 4403-2003 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 9 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K974901 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-06-06 |