MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-06-14 for COBAS 4800 HPV TEST, CE-IVD 05235901190 manufactured by Roche Molecular Systems.
[2728568]
A customer from (b)(6) is alleging discrepant results were generated during a validation study using the kit cobas 4800 hpv amp/det 240t ce-ivd (m/n 05235901190; lot p05296) they identified 8 samples out of 120 that generated discrepant results. None of the results have been reported to physicians.
Patient Sequence No: 1, Text Type: D, B5
[9925713]
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. The associated us product is m/n 05235880190. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[17353423]
Type of report: follow up report 1. Type of follow-up: additional information / device evaluation. Device evaluated by manufacturer: yes. A customer from the (b)(6) stated that, while performing a validation study with the cobas 4800 hpv test, ce-ivd, they generated (b)(4) during the reproducibility section of the study. Five of the samples, sample ids ((b)(4)) generated ct values that were close to the limit of detection of the test, according to the package insert. Thus it is expected that these samples may waiver between negative and positive if retested. Sample ids (b)(4), tested on (b)(4) 2011, respectively, originally did not generate a ct value for the discrepant target. However, when retested on (b)(4) 2011, respectively, the samples generated a positive ct, within the normal range and not close to lod. This discrepancy may be due to cell clumping, where very heterogeneous samples may generate variations in ct values. Sample id (b)(4) generated overall inconsistent ct values. The ct values generated between testing on (b)(4) 2012, showed ct differences that can be expected in very heterogeneous samples. This discrepancy is also likely due to cell clumping or incomplete specimen mixing. Investigative testing of the customer returned samples generated results similar to those obtained by the customer. Retain testing of complaint kit batch p05296 met specification. The other kit batch n14750 expired before the customer complaint case was created and additional testing was not possible. The result discrepancies observed in the customer's validation study were due to sample specific issues. Five of the samples were close to lod and three of the samples may have had cell clumping or incomplete specimen mixing. There is no indication of a product non-conformance with the cobas 4800 hpv test. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2012-00026 |
| MDR Report Key | 2616051 |
| Report Source | 01,05 |
| Date Received | 2012-06-14 |
| Date of Report | 2012-08-17 |
| Date of Event | 2011-12-19 |
| Date Mfgr Received | 2012-08-17 |
| Date Added to Maude | 2012-10-11 |
| 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 | 2012-06-14 |
| Catalog Number | 05235901190 |
| Lot Number | P05296 |
| Device Expiration Date | 2012-11-30 |
| 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 | 2012-06-14 |