MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-22 for COBAS? AMPLIPREP/COBAS? TAQMAN? CMV TEST 04902025190 manufactured by Roche Molecular Systems.
[68280752]
The investigation into the case issue is ongoing. A supplemental report will be provided at the end of the investigation. The udi for the kit cap-g/ctm (b)(6) 72 tests us-ivd is (b)(4). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[68280753]
A customer from the united states reported under-quantitated results were obtained on multiple samples collected from the same patient when tested with the cap-g/ctm (b)(6) 72 tests us-ivd compared to other laboratory-developed tests. The cap-g/ctm (b)(6) 72 tests us-ivd generated results ranging from (b)(6) on various sample collections in the period of (b)(6) 2016 to (b)(6) 2017. These same samples generated results that ranged from (b)(6) when tested in other laboratory developed tests. The patient is currently being treated with ganciclovir for (b)(6) infection.
Patient Sequence No: 1, Text Type: D, B5
[73854651]
A customer from the united states reported under-quantitated results were obtained on multiple samples collected from the same patient when tested with the cap-g/ctm cmv 72 tests us-ivd compared to other laboratory-developed tests. The patient sample was sequenced through the complaint investigation. It was determined that there were two mismatches between one of the roche cap/ctm cmv test primers and the patient cmv sequence. Analysis using computer models and other knowledge of the sequence suggested that the sequence variation in the specimen would contribute to the observed under-quantification by the cap/ctm cmv test. Per the test's instructions for use, though rare, mutations within the highly conserved regions of the viral genome covered by the cobas? Ampliprep/cobas? Taqman? Cmv test primers and/or probes may result in the under-quantitation of or failure to detect the virus. Additionally, investigative testing of the complaint kit lot did not reproduce the customer's allegation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2017-00003 |
| MDR Report Key | 6350628 |
| Date Received | 2017-02-22 |
| Date of Report | 2017-04-13 |
| Date of Event | 2017-01-19 |
| Date Mfgr Received | 2017-01-23 |
| Date Added to Maude | 2017-02-22 |
| 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 TIMOTHY BLAIR |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537918 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS? AMPLIPREP/COBAS? TAQMAN? CMV TEST |
| Generic Name | CYTOMEGALOVIRUS (CMV) DNA QUANTITATIVE ASSAY |
| Product Code | PAB |
| Date Received | 2017-02-22 |
| Model Number | NA |
| Catalog Number | 04902025190 |
| Lot Number | X03839 |
| ID Number | NA |
| Device Expiration Date | 2017-07-31 |
| 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 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-22 |