MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-23 for COBAS AMPLIPREP / COBAS TAQMAN CMV TEST US-IVD 04902025190 manufactured by Roche Molecular Systems.
[34249683]
Patient Sequence No: 1, Text Type: N, H10
[34249684]
A customer site (b)(6) in the us filed a complaint alleging that, on (b)(6) 2015, discrepant cmv results were generated between the cobas? Ampliprep/cobas? Taqman? (cap/ctm) cmv test (plasma specimens) and a qpcr lab developed test (ldt) (serum specimens) from viracor (two different samples were collected at the same time). The cap/ctm cmv test generated significantly lower cmv viral titers than the ldt test. The cap/ctm test was below the lower limit of quantitation (lloq) for 9 of the specimens tested. The samples were provided by the customer for sequencing analysis. The sequencing results generated on (b)(6) 2015 indicated a mismatch with the cap/ctm cmv test. In the cap/ctm cmv instructions for use (ifu), under the section procedural precautions / limitations of the procedures, it is stated: 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. On (b)(6) 2015, while on a conference call with the customer, roche learned that the patient with the discrepant results may be critically ill and a delay in treatment for cmv resulted from the under-quantitation of the cap/ctm cmv test. On (b)(6) 2015, clinicians reported that the affected patient? S cmv viremia has been successfully treated. Treatment has been stopped after two results
| Report Number | 2243471-2015-00015 |
| MDR Report Key | 5323190 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-23 |
| Date of Report | 2015-12-23 |
| Date of Event | 2015-09-25 |
| Date Mfgr Received | 2015-11-23 |
| Date Added to Maude | 2015-12-23 |
| 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 VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537722 |
| 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 AMPLIPREP / COBAS TAQMAN CMV TEST US-IVD |
| Generic Name | CYTOMEGALOVIRUS (SMV) DNA QUANTITATIVE ASSAY |
| Product Code | PAB |
| Date Received | 2015-12-23 |
| Model Number | NA |
| Catalog Number | 04902025190 |
| Lot Number | W04477 |
| ID Number | NA |
| Device Expiration Date | 2016-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HIGHWAY 202S NA BRANCHBURG NJ 088763733 US 088763733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-23 |