MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-08-10 for CAP/CTM CMV TEST 04902068190 manufactured by Roche Molecular Systems.
[51747420]
There are no clear guidelines for when to start pre-emptive (b)(6) therapy for (b)(6) due to differences in practice from center to center and a great heterogeneity among patients leading to very different risks of disease. Unless this was a very high risk stem cell transplant recipient, many clinicians would not initiate preemptive treatment for a (b)(6) viral load of(b)(6) in the absence of symptoms. (b)(6) symptoms could include diarrhea, abdominal pain, anorexia, fever and malaise. If the patient already had colitis symptoms at that time, then many clinicians would either start treatment or do an investigation (endoscopy plus biopsy) to evaluate for (b)(6), as (b)(6) disease occasionally occurs without (b)(6). Copies are not standardized, and one assay's (b)(6) copy can differ from another's by multiple logs. Therefore a direct comparison between the roche test results (iu/ml) and the second hospital's results (in copies/ml) is impossible. Only two tests both reporting in international units (cap/ctm and rikshospitalet) can be compared. Through the course of the investigation, no product non-conformance was identified; the retain kit was tested and met specifications. The initial patient samples were not available for further evaluation; the cause for the discrepancies remains unknown. The udi for the cap/ctm cmv test ce-ivd is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[51747421]
A customer from (b)(6) alleged under-quantitation of a patient sample while using the cobasampliprep/cobas taqman (cap/ctm) cmv test. It was indicated that the patient had returned multiple results near (b)(6) using the cap/ctm cmv test while lab developed tests (ldts) reported values above (b)(6). The patient was not treated based on the (b)(6) result and subsequently developed life-threatening (b)(6) potentially due to a 2-week delay in treatment. Once treated, the patient's health improved and the final blood draw generated results below the lower level of quantitation (lloq) or target not detected on both the cobas ampliprep/cobas taqman (cap/ctm) cmv test and the ldt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2016-00016 |
| MDR Report Key | 5865291 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-08-10 |
| Date of Report | 2016-08-10 |
| Date of Event | 2016-05-30 |
| Date Mfgr Received | 2016-07-11 |
| Date Added to Maude | 2016-08-10 |
| 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 | 9082537569 |
| 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 | CAP/CTM CMV TEST |
| Generic Name | CYTOMEGALOVIRUS (CMV) DNA QUANTITATIVE ASSAY |
| Product Code | PAB |
| Date Received | 2016-08-10 |
| Model Number | NA |
| Catalog Number | 04902068190 |
| Lot Number | W12290 |
| ID Number | NA |
| Device Expiration Date | 2017-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2016-08-10 |