MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-05-02 for COBAS 4800 HPV TEST, US-IVD 05235880190 manufactured by Roche Molecular Systems.
[22191273]
A customer site in the us filed a complaint alleging that a (b)(6) result was generated when using the cobas 4800 (b)(4) test. The sample tested (b)(6) for (b)(6) on (b)(6) 2013. The result was released to the physician. The customer ran this sample on (b)(6) 2013 as part of a lot validation run and the sample generated (b)(6) result. This result was not reported to the physician. The customer believes that the original (b)(6) result is correct.
Patient Sequence No: 1, Text Type: D, B5
[22364809]
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
[30041587]
(b)(4). A customer site in the us filed a complaint alleging that (b)(6) results for (b)(6) were generated when using the cobas 4800 hpv test. The sample initially tested (b)(6) for (b)(6). The customer re-ran this sample twice and the sample generated a (b)(6) result both times. The customer reported the initial (b)(6) result and questioned the (b)(6) results. The sample in question was provided for investigative testing, which generated a (b)(6) result. The retain complaint kit generated valid results which met specification. There is no indication of a product malfunction. It is plausible that the (b)(6) result generated at the customer site is due to the effects of the heterogeneous cell specimens. Heterogeneous specimens can give drastically varying results between the initial test and subsequent testings. (b)(6) specimens should be vortexed as described in the package insert to in order to ensure even distribution of target in the testing sample. It was suggested that the customer discuss the results with the physician and correlate with cytology and patient history. It was also suggested that a new collection be obtained for testing. Patient treatment information was requested, but this information was not available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2013-00009 |
| MDR Report Key | 3090418 |
| Report Source | 05 |
| Date Received | 2013-05-02 |
| Date of Report | 2013-05-23 |
| Date of Event | 2013-04-03 |
| Date Mfgr Received | 2013-05-23 |
| Date Added to Maude | 2013-07-09 |
| 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 | 2013-05-02 |
| Catalog Number | 05235880190 |
| 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 | 2013-05-02 |