MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-04-20 for FACTOR V LEIDEN KIT 03610179001 manufactured by Roche Molecular Systems.
[1054369]
Customer has experienced multiple control failures while using the lightcycler factor v leiden test. The customer is using an off-label practice of manipulating the software temperature range on the melting curve analysis graph to generate valid controls. Eleven data files containing control failures were provided by the customer. Five of the eleven runs still show control failure after the temperature adjustment. The customer has been reporting patient result from the runs with the failed controls. Reporting results from invalid runs risks the release of erroneous results.
Patient Sequence No: 1, Text Type: D, B5
[8146509]
Review of the product labeling identified the following text in the quality control section of the package insert: "the assay result for the factor v leiden negative control should always be "negative". If this is not the case, the whole run is flagged as invalid. The entire procedure (specimen preparation, amplification and detection) must be repeated. If the negative control consistently gives a non-negative result, contact your local roche representative for technical assistance. " "the assay result for the factor v leiden ct should always be genotyped as "het". If this is not observed, the run is invalid and the entire procedure (specimen preparation, amplification and detection) must be repeated. If the positive control consistently fails for the heterozygous genotype, contact your local roche representative for technical assistance. " also in the expected values/interpretation of results section of the package insert it states, "ensure that the control results for the run were valid. If the run is invalid, repeat the entire run (specimen preparation, amplification and detection). Investigation into the root cause of 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 the unequal amplification results between the two and therefore the result is interpretted as invalid. 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 results of the lc factor v assay would be whether to discontinue anticoagulation after a standard 3 - 6 months or to continue anticoagulation indefinitely. Since the patient is already under treatment, there is no risk of delaying treatment from the factor v control failure that led to an invalid run. The treating clinician would continue the anticoagulation therapy until a valid factor v assay was completed. Due to 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 | 2243471-2009-00011 |
| MDR Report Key | 1364427 |
| Report Source | 04 |
| Date Received | 2009-04-20 |
| Date of Report | 2009-04-20 |
| Date of Event | 2009-02-16 |
| Date Mfgr Received | 2009-03-22 |
| Date Added to Maude | 2010-03-03 |
| 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 | MR. ROBERT PIGOZZI |
| Manufacturer Street | 4300 HACIENDA DRIVE |
| Manufacturer City | PLEASANTON CA 945880900 |
| Manufacturer Country | US |
| Manufacturer Postal | 945880900 |
| Manufacturer Phone | 9257308272 |
| Manufacturer G1 | ROCHE APPLIED SCIENCE |
| Manufacturer City | PENZBERG, 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 MUTATION DETECTION SYSTEM |
| Product Code | NPQ |
| Date Received | 2009-04-20 |
| Catalog Number | 03610179001 |
| Lot Number | 14674120 |
| Device Expiration Date | 2009-12-31 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 4300 HACIENDA DRIVE PLEASANTON CA 94588090 US 94588 0900 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-20 |