MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-09-13 for HYBRID CAPTURE 2 RAPID CAPTURE SYSTEM 9000192 6000-3101 manufactured by Digene Corp..
[260814]
Hybrid capture 2 (hc2) rapid capture system (rcs) is a semi-automated instrument application of the hc2 ct/gc, ct-id and gc-id dna tests. The application uses a robotic microplate processor that automates the pipetting and microplate handling steps of the hc2 tests. Rcs unit 2932 was received march 29, 2002. At the conclusion of routine in-house testing of the new unit in 2002, the digene technician reported "no mechanical or functional problems during the inspection"; however, the presence of "air bubbles" in the specimen was noted prior to transfer. The bubbles were removed and all specimens transferred successfully. Simulated specimens were in use for instrument acceptance testing. No patient specimens were involved in the report. The decision to file an adverse event report was not based on this individual event, but on a product performance investigation initiated in response to three reports from digene employees. A consolidated investigation conduded that the presence of an air pocket, also referred to as air bubbles, in a cervical brush specimen may cause a missed or partial specimen transfer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2002-00002 |
| MDR Report Key | 417450 |
| Report Source | 07 |
| Date Received | 2002-09-13 |
| Date of Report | 2002-06-06 |
| Date of Event | 2002-06-06 |
| Date Mfgr Received | 2002-06-06 |
| Device Manufacturer Date | 2002-02-01 |
| Date Added to Maude | 2002-09-23 |
| 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, QSRC DIRECTOR |
| Manufacturer Street | 1201 CLOPPER ROAD |
| Manufacturer City | GAITHERSBURG MD 20878 |
| Manufacturer Country | US |
| Manufacturer Postal | 20878 |
| Manufacturer Phone | 3019447274 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Removal Correction Number | PPI07/02A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYBRID CAPTURE 2 RAPID CAPTURE SYSTEM |
| Generic Name | ROBOTIC PLATE PROCESSOR FOR HC2 CT/GC DNA TEST |
| Product Code | LSK |
| Date Received | 2002-09-13 |
| Model Number | 9000192 |
| Catalog Number | 6000-3101 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 406481 |
| Manufacturer | DIGENE CORP. |
| Manufacturer Address | 1201 CLOPPER RD GAITHERSBURG MD 20878 US |
| Baseline Brand Name | HYBRID CAPTURE 2 RAPID CAPTURE SYSTEM |
| Baseline Generic Name | ROBOTIC PLATE PROCESSOR FOR HC2 CT/GC DNA TEST |
| Baseline Model No | 9000192 |
| Baseline Catalog No | 6000-3101 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-09-13 |