MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-06-12 for FACTOR V LEIDEN KIT 03610179001 manufactured by Roche Molecular Systems, Inc.
[19281704]
The customer reported 6 run failures, which affected 13 patient results (not specified whether these were 13 unique patients), due to an invalid factor v leiden control template (fvl ct). The customer was performing an off-label practice by reporting test results from test runs with invalid controls; these test runs should have been invalidated as per the factor v leiden kit labeling. Reporting invalid test results may result in the release of erroneous, but believable test results.
Patient Sequence No: 1, Text Type: D, B5
[19511600]
Review of the product labeling identified the following text within the quality control section of the package insert: "the assay result for the factor v leiden ct should always be 'het'. If this is not observed, the run is invalid and pcr must be repeated. " there is no medical risk associated with a failed control as the generated results are invalid and not to be reported. The primary medical treatment decision that would be based on the result of the lc factor v leiden test would be whether to discontinue anticoagulation after a standard 3 - 6 months or to continue anticoagulation indefinitely. Since the patients would already be under treatment when the test was being performed, there is no risk of delaying treatment due to a factor v control failure. The treating clinician would continue the anticoagulation therapy until a valid factor v assay result was reported. Investigation into the root cause of the control failures was performed. The root cause was determined to be due to the generation of supercoiling of the wildtype and mutation plasmids in the control that cause unequal amplification results between the two plasmids, and therefore, the result is interpreted as invalid. Due to the low level of risk associated with a failed control, further mitigation is not being considered. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2009-00013 |
| MDR Report Key | 1401109 |
| Report Source | 04 |
| Date Received | 2009-06-12 |
| Date of Report | 2009-05-20 |
| Date of Event | 2009-04-27 |
| Date Mfgr Received | 2009-05-22 |
| Date Added to Maude | 2011-04-22 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. LEXIE PIEPER |
| Manufacturer Street | 1080 US HWY 202 |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537855 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH (ROCHE APPLIED SCIENCES) |
| Manufacturer Street | NONNENWALD 2 |
| Manufacturer City | PENZBURG, 82377 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 82377 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FACTOR V LEIDEN KIT |
| Generic Name | FACTOR V LEIDEN DNA MUTATION DETECTION SYSTEMS, PRODUCT CODE: NPQ |
| Product Code | NPQ |
| Date Received | 2009-06-12 |
| Catalog Number | 03610179001 |
| Lot Number | 14674120 |
| Device Expiration Date | 2009-12-31 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC |
| Manufacturer Address | 1080 US HWY 202 BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-12 |