MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-05-23 for COBAS 4800 HPV TEST, CE-IVD 05235901190 manufactured by Roche Molecular Systems.
[15267826]
A customer in (b)(6) reported that a patient that was diagnosed as having cervical adenocarcinoma by colposcopy and biopsy tested (b)(6) three times for all high risk (b)(6) types with the cobas 4800 (b)(4), ce-ivd. The sample tested was a liquid cytology sample collected in (b)(6), a local-branded cell collection media, which is off-label.
Patient Sequence No: 1, Text Type: D, B5
[15598847]
A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing. The outcome of the investigation will be communicated through a follow-up report. The associated us product is m/n 05235880190 p100020. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[24684294]
Date additional information received by the manufacturer (07-09-2013). Device evaluated by manufacturer: yes. No failure detected and product within specifications. Conclusion: unable to confirm complaint. Conclusion: off-label, unapproved, or contraindicated use. A patient diagnosed with adenocarcinoma in colposcopy generated negative results during initial testing with the cobas 4800 hpv test. Repeat testing was performed and negative results were generated for "other high risk hpv. " the sample was a liquid cytology sample collected in a local-branded cell collection media: (b)(4), which is considered off-label. Although requested, the sample was not available for testing so the allegation could not be confirmed. The cobas 4800 hpv test has been validated for the use of cervical specimens collected in cobas pcr cell collection media, preservcyt, and surepath preservative fluid. The performance of a sample collected in the off-label (b)(4) cell collection media has not been evaluated by roche, and is considered an off-label application of the test. The retain kits were tested and met specifications; therefore, there is no indication of a product non-conformance. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2013-00013 |
| MDR Report Key | 3127363 |
| Report Source | 01,05 |
| Date Received | 2013-05-23 |
| Date of Report | 2013-07-09 |
| Date of Event | 2013-04-24 |
| Date Mfgr Received | 2013-04-24 |
| Date Added to Maude | 2013-08-05 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202S |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 4800 HPV TEST, CE-IVD |
| Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMA VIRUS |
| Product Code | MAQ |
| Date Received | 2013-05-23 |
| Catalog Number | 05235901190 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HW 202S BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-23 |