MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-03-03 for HYBRID CAPTURE II CT-ID TEST 5135-1050 IVT manufactured by Digene Corporation.
[19144068]
Clinical laboratory reported an elevated number of positive specimen results with rlu to cutoff values in the range of 1. 0 to 10. 0. The lab reported that positive specimen prevalence had increased to greater than 20 specimens per plate, as compared to typical positive specimen prevalence of approximately 1-4 specimens per plate. The report indicated that the assays met specified quality control and assay calibration criteria. Initial evaluation of the report did not identify the report as an adverse event. Digene identified the requirement to submit an mdr in january, 2003, after investigation of multiple similar complaint reports confirmed the reported aberrant product performance. The reports were characterized by an increased number of low-signal positive specimen results using the hybrid capture 2 hpv dna assays, all of which were obtained when performing acceptable assays according to the quality control and assay calibration verification criteria that are provided in the product package insert. At the time that the combined investigation was initiated in january, 2003, 11 customers had reported complaints involving a total of eight kit lots. An additional two kit lots have been reported since that time, including one customer report received from outside the united states for use of the hybrid capture ii ct-id test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2003-00014 |
| MDR Report Key | 446937 |
| Report Source | 06 |
| Date Received | 2003-03-03 |
| Date of Report | 2003-01-31 |
| Date Mfgr Received | 2003-01-31 |
| Device Manufacturer Date | 2002-12-01 |
| Date Added to Maude | 2003-03-12 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARA SCHROEDER |
| 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 | PM |
| Previous Use Code | 3 |
| Removal Correction Number | 1122376-02/20/2003-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYBRID CAPTURE II CT-ID TEST |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | LSW |
| Date Received | 2003-03-03 |
| Model Number | NA |
| Catalog Number | 5135-1050 IVT |
| Lot Number | 2443 |
| ID Number | NA |
| Device Expiration Date | 2003-09-24 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 435900 |
| Manufacturer | DIGENE CORPORATION |
| Manufacturer Address | 1201 CLOPPER ROAD GAITHERSBURG MD 20878 US |
| Baseline Brand Name | HYBRID CAPTUARE II CT-ID TEST |
| Baseline Generic Name | IN VITRO DIAGNOSTIC |
| Baseline Model No | NA |
| Baseline Catalog No | 5135-1050 IVT |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-03-03 |