MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-18 for COBAS 4800 HPV TEST, US-IVD 05235880190 manufactured by Roche Molecular Systems.
[3970219]
A customer site in the us filed a complaint alleging that a (b)(6) result was generated for one patient sample when using the cobas 4800 hpv test. Sample id (b)(6) generated a (b)(6) result for other (b)(6) on (b)(6) 2013. When repeated on (b)(6) 2013 the result was (b)(6). The customer released the (b)(6) result. No patient information was provided and it is unknown if any patient treatment was affected.
Patient Sequence No: 1, Text Type: D, B5
[11465165]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2013-00038 |
| MDR Report Key | 3526031 |
| Report Source | 05 |
| Date Received | 2013-12-18 |
| Date of Report | 2013-11-27 |
| Date of Event | 2013-11-26 |
| Date Mfgr Received | 2013-11-27 |
| Date Added to Maude | 2014-03-31 |
| 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 | 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, US-IVD |
| Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMA VIRUS |
| Product Code | MAQ |
| Date Received | 2013-12-18 |
| Catalog Number | 05235880190 |
| Lot Number | S01204 |
| Device Expiration Date | 2015-05-31 |
| Device Eval'ed by Mfgr | N |
| 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 | 2013-12-18 |