MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-03-31 for COBAS 4800 HPV TEST 05235910190 manufactured by Roche Molecular Systems.
[71463770]
The investigation into the case issue is on-going. A supplementation report will be provided at the end of the investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[71463771]
(b)(6) customer reported the generation of discrepant (b)(6) results for a patient between the cobas 4800 hpv test ((b)(6)) and other tests ((b)(6)). Samples (different collections) were tested for the same patient in (b)(6) 2015 and (b)(6) 2016. All results generated with the cobas 4800 hpv test were (b)(6), ((b)(6) 2016). Recent testing ((b)(6) 2016) using other tests (seegene anyplex ii hpv28 test; genxpert hpv test; "in-house" protocol) generated (b)(6) results. A biopsy from (b)(6) 2016 showed high-grade squamous intraepithelial lesion (hsil) and squamous cell cancer. It is not known if the patient had cancer in (b)(6) 2015, when she was originally tested (b)(6) with the cobas 4800 hpv test. Roche has requested remaining sample to perform further analysis.
Patient Sequence No: 1, Text Type: D, B5
[75940312]
A (b)(6) customer reported the generation of discrepant (b)(6) results for a patient between the cobas 4800 hpv test (b)(6) and other tests (b)(6). A biopsy from (b)(6) 2016 showed high-grade squamous intraepithelial lesion (hsil) and squamous cell cancer. The sample from (b)(6) 2016 was sent to roche for sequencing analysis. The sample was subjected to sequencing using all pgmy primers and (b)(6) type 16 specific primers. Pgmy would confirm the presence of (b)(6) in the sample while the type specific primers would generate sequence information under the assay oligos binding sites. Different volume inputs, number of cycles were tested to increase the probability of obtaining the targeted amplicon. Despite several attempts to obtain (b)(6) sequences from the samples, no viral sequences were obtained. The lack of (b)(6) sequence does not necessarily mean that no (b)(6) was present in the samples. The lack of sequence information could be due to inhibitory factors that have a (b)(6) impact to the cobas hpv assay performance or the sequence heterogeneity affecting the primers used for sequencing. From the internal investigation performed on the product, no related issues to the customer allegation were identified. After filing the initial mdr report, information was provided, specifically relating to the patient and the initial reporter. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2017-00007 |
| MDR Report Key | 6450462 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-03-31 |
| Date of Report | 2017-05-16 |
| Date of Event | 2017-03-06 |
| Date Mfgr Received | 2017-03-06 |
| Date Added to Maude | 2017-03-31 |
| 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 | 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 | 3 |
| Brand Name | COBAS 4800 HPV TEST |
| Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
| Product Code | MAQ |
| Date Received | 2017-03-31 |
| Model Number | NA |
| Catalog Number | 05235910190 |
| Lot Number | X08046 |
| ID Number | NA |
| Device Expiration Date | 2018-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 08869 US 08869 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-31 |