MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-30 for COBAS Z 480 ANALYZER 05200881001 manufactured by Roche Molecular Systems.
[71577422]
The investigation into the case issue is currently on-going. A supplemental report will be provided at the end of the investigation. The udi for the cobas z 480 analyzer is (b)(4). (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[71577423]
A (b)(6) customer reported that the cobas z 480 analyzer (part of the cobas 4800 system) generated a high frequency of (b)(6) results for samples tested in a specific row on the 96-well microwell plate. The customer suspects that the positive hpv results are falsely positive; no further information has been provided relating to the patients or the allegation of result discrepancies. The local (b)(4) affiliate replaced the loading unit (hardware) on the cobas z 480 analyzer, and no further issues were alleged to be observed. The loading unit was requested to be returned for further investigation, which is currently on-going.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2017-00006 |
| MDR Report Key | 6447296 |
| Date Received | 2017-03-30 |
| Date of Report | 2017-07-13 |
| Date of Event | 2017-02-28 |
| Date Mfgr Received | 2017-03-01 |
| Date Added to Maude | 2017-03-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | COBAS Z 480 ANALYZER |
| Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
| Product Code | MAQ |
| Date Received | 2017-03-30 |
| Model Number | NA |
| Catalog Number | 05200881001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-03-30 |