MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-05 for COBAS 4800 HPV TEST 05235910190 manufactured by Roche Molecular Systems.
[105185502]
The investigation into the case issue is on-going. A supplemental report will be provided at the end of the investigation. (b)(4). The udi for the kit cobas 4800 hpv amp/det 960t ce-ivd is (b)(4). Patient 1: (b)(6). Female. Patient 2: (b)(6). Female. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[105185503]
A customer from (b)(6) alleged (b)(6) test results when compared to cytology findings for 2 patients. Both samples were thinprep cervical samples, practitioner-collected. Samples tested were aliquots from the original thinprep vial. Patient 1 (sample was collected on (b)(6) 2018, tested (b)(6) 2018): cobas 4800 hpv test? (b)(6) for all (b)(6) detected for the test. This result was reported to the requesting doctor. Liquid-based cytology slide was prepared on (b)(6) 2018, manual examination (no imaging system used): high grade squamous intraepithelial lesion (hsil). No endocervical cells are present. The slide is satisfactory for assessment. Squamous cells show cin3. Patient 2 (sample was collected on (b)(6) 2018, tested (b)(6) 2018): cobas 4800 hpv test? (b)(6) for all (b)(6) detected for the test. This result was reported to the requesting doctor. Liquid-based cytology slide was prepared on (b)(6) 2018, manual examination (no imaging system used): high grade squamous intraepithelial lesion (hsil). Endocervical cells are present. The slide is satisfactory for assessment. Squamous cells present show cin 3 and (b)(6) effect. History of previous abnormality is noted. Patient sample materials were requested to perform further analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2018-00003 |
| MDR Report Key | 7398753 |
| Date Received | 2018-04-05 |
| Date of Report | 2018-06-18 |
| Date of Event | 2018-01-19 |
| Date Mfgr Received | 2018-03-09 |
| Date Added to Maude | 2018-04-05 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COBAS 4800 HPV TEST |
| Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
| Product Code | MAQ |
| Date Received | 2018-04-05 |
| Model Number | NA |
| Catalog Number | 05235910190 |
| Lot Number | Y12819 |
| ID Number | NA |
| Device Expiration Date | 2019-02-28 |
| 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 | ROCHE MOLECULAR SYSTEMS NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-05 |