MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-12-24 for COBAS 4800 HPV TEST, CE-IVD 05235901190 manufactured by Roche Molecular Systems.
[4118048]
A customer from the (b)(6) filed a complaint alleging that discrepant (b)(6) results were generated for one patient specimen in three separate runs when using the cobas 4800 hpv test with three different kit lots (r15771, r16114, s01192). The customer was using the previously tested (b)(6) patient specimen as an external (b)(4) control and some of the targets tested (b)(4) in the three runs. Mdr 2243471-2013-00040 is being filed for the results generated with cobas hpv test lot r15771. Mdr 2243471-2013-00041 is being filed for the results generated with cobas hpv test lot r16114. Mdr 2243471-2013-00042 is being filed for the results generated with cobas hpv test lot s01192.
Patient Sequence No: 1, Text Type: D, B5
[11462342]
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
[24935355]
The complaint alleged discrepant (b)(6) results were generated for one patient specimen when using the cobas 4800 (b)(6) test. The customer was using the previously tested negative (b)(6) patient specimen as an external negative control and it tested (b)(6) on a subsequent run. The customer selected the sample randomly as an internal negative control as per the cervical screening guidelines in the (b)(6). Although requested, the initial runs for the alleged sample in which the sample tested negative were not available for ct comparison. As the 'internal negative control', used during the customer's runs are selected at random, the customer has admitted that it is possible that the incorrect sample was selected for this subsequent run. The customer uses a manual sample ordering system; they do not give these particular sample a unique identifiers therefore there is no way of checking if the correct sample was used as the 'internal negative control'. It is not recommended to use previously tested patient samples as 'internal negative controls' as result discrepancies may be generated if the sample (s) contain a concentration of virus near the limit of detection of the test; additionally, the cobas 4800 (b)(6) test requires and has been validated to use the test's negative control. Retain testing of the complaint kit met specification. The sample in question is no longer available for investigative testing. There is no indication of a product non-conformance. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2013-00042 |
| MDR Report Key | 3535288 |
| Report Source | 01,05 |
| Date Received | 2013-12-24 |
| Date of Report | 2014-03-07 |
| Date of Event | 2013-10-28 |
| Date Mfgr Received | 2014-03-07 |
| Date Added to Maude | 2014-04-02 |
| 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, CE-IVD |
| Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMA VIRUS |
| Product Code | MAQ |
| Date Received | 2013-12-24 |
| Catalog Number | 05235901190 |
| Lot Number | S01192 |
| Device Expiration Date | 2015-03-31 |
| 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 | 2013-12-24 |