MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-17 for COBAS 4800 HPV TEST 05235910190 manufactured by Roche Molecular Systems.
[80412149]
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 kit cobas 4800 (b)(6) amp/det 240t ce-ivd is (b)(4). (b)(4). The corresponding us kit material number is (b)(4). Pma# p100020.
Patient Sequence No: 1, Text Type: N, H10
[80412150]
A customer from (b)(6) observed inter-assay discrepant results for a patient sample tested with cobas 4800 (b)(6) test and non-roche assay (digene). Results generated on cobas 4800 were (b)(6) for (b)(6), whereas the non-roche assay generated (b)(6) results. Furthermore, cytology results showed high grade lesions. This was part of an evaluation of the cobas 4800 test at a customer site. No result on the cobas 4800 test was reported to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2017-00019 |
| MDR Report Key | 6719047 |
| Date Received | 2017-07-17 |
| Date of Report | 2017-11-17 |
| Date of Event | 2017-02-22 |
| Date Mfgr Received | 2017-06-20 |
| Date Added to Maude | 2017-07-17 |
| 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 HIGHWAY 202 SOUTH 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 | 0 |
| Brand Name | COBAS 4800 HPV TEST |
| Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
| Product Code | MAQ |
| Date Received | 2017-07-17 |
| Model Number | NA |
| Catalog Number | 05235910190 |
| Lot Number | X09600 |
| ID Number | NA |
| Device Expiration Date | 2018-05-31 |
| 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 |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-17 |