MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-10 for COBAS HPV TEST, US-IVD 05235898190 manufactured by Roche Molecular Systems, Inc..
[107881604]
The investigation into this issue is currently on-going. The outcome of this investigation will be communicated through a follow-up report. The udi for the cobas 4800 hpv amp/det 960t us-ivd is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[107881605]
A us customer alleged the generation of a (b)(6) result with the cobas 4800 hpv test, for a patient sample that demonstrated a large, rapidly growing squamous cell carcinoma (scc), and was (b)(6) by immunohistochemistry and for (b)(6) with an (b)(6) rna ish test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2018-00006 |
| MDR Report Key | 7503154 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-10 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-04-11 |
| Date Mfgr Received | 2018-04-11 |
| Date Added to Maude | 2018-05-10 |
| 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 | 3 |
| Manufacturer Contact | NA STACIE-ANN CREIGHTON |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537112 |
| Manufacturer G1 | NA |
| Manufacturer Street | NA NA |
| Manufacturer City | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS HPV TEST, US-IVD |
| Generic Name | HUMAN PAPILLOMAVIRUS DNA DETECTION KIT |
| Product Code | MAQ |
| Date Received | 2018-05-10 |
| Model Number | NA |
| Catalog Number | 05235898190 |
| Lot Number | Y20292 |
| ID Number | NA |
| Device Expiration Date | 2019-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-10 |