MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-05-10 for COBAS 4800 HPV TEST, CE-IVD 05235901190 manufactured by Roche Molecular Systems.
[9871332]
The customer alleged that 2 patient samples generated discrepant results with the cobas 4800 hpv amp/det 240t ce-ivd test as compared to a comparator test (digene-qiagen) for (b)(6) detection. This report is for sample number 4431859130, mdr 2243471-2012-00021 was filed for sample number (b)(4). Specifically the cobas 4800 hpv amp/det 240t ce-ivd generated (b)(6) results for (b)(6) and the comparator test generated (b)(6) results for (b)(6). Investigative testing of the complaint sample using the cobas 4800 hpv test generated the same valid (b)(6) results as reported by the customer. Kit batch retain testing met specification. The high pure hpv dna test by digene- qiagen is a nucleic acid hybridization assay with signal amplification that utilizes microplate chemiluminescent detection. This unit of measure uses the amount of emitted light and is measured as relative light units (rlus) on a luminometer. The intensity of the light emitted denotes the presence or absence of target dna in the specimen. The cobas 4800 hpv test uses real time pcr technology and measure the fluorescence emitted of the polymerase chain reaction. The number of cycles at which the relative fluorescence exceeds the threshold is the threshold cycle (ct). These two units of measure are not directly comparable. The hybrid capture hpv dna test measures its limit of detection in pg/ml (a unit of mass density) and the cobas 4800 hpv test measures its limit of detection in copies /ml (a unit of viral load). These two units and test results are not directly comparable. The differences seen between the assays could be due, but not limited to, sensitivity differences between the tests, the ability of the digene-qiagen test to detect low risk hpv genotypes , and sample collection methods. The cobas 4800 hpv test performed as expected. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[20917373]
A customer site in (b)(6) is alleging discrepant results were generated with the cobas 4800 hpv amp/det 240t ce-ivd and a comparator test (digene-qiagen) for hpv detection. Specifically the cobas 4800 hpv amp/det 240t ce-ivd generated negative results for hpv 16, hpv 18 and other high risk hpv and the comparator test generated positive results for hpv 16, hpv 18, and other high risk hpv. The sample was first tested on (b)(6) 2012 and repeat testing was performed on (b)(6) 2012. The repeat test confirmed the original results.
Patient Sequence No: 1, Text Type: D, B5
[21150653]
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 related us-ivd cobas 4800 hpv test is m/n (b)(4). Pma p100020. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2012-00022 |
| MDR Report Key | 2568747 |
| Report Source | 01,05 |
| Date Received | 2012-05-10 |
| Date of Report | 2012-05-25 |
| Date of Event | 2012-04-03 |
| Date Mfgr Received | 2012-05-25 |
| Date Added to Maude | 2012-09-20 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2012-05-10 |
| Catalog Number | 05235901190 |
| Lot Number | P09699 |
| Device Expiration Date | 2012-11-29 |
| 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 | 2012-05-10 |