MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-04-06 for FACTOR V LEIDEN KIT 03610179001 manufactured by Roche Diagnostics Gmbh.
[1055720]
Customer reported out results from two invalid lightcycler factor v leiden test runs. The runs were invalid due to failed controls. Reporting results from invalid runs risks the release of erroneous results.
Patient Sequence No: 1, Text Type: D, B5
[8183367]
No investigation will be performed as there is no evidence of a product non-conformance. Review of the package insert identified the following text in the quality control section: "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 positve control consistently fails for the heterozygous genotype, contact your local roche representative for technical assistance. " also in the expected values/interpretation of results section it states, "ensure that the control results for the run are valid. If the run is invalid, repeat the entire run (specimen preparation, amplification and detection). "
Patient Sequence No: 1, Text Type: N, H10
[15451239]
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 interpreted 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2009-00007 |
| MDR Report Key | 1355461 |
| Report Source | 04 |
| Date Received | 2009-04-06 |
| Date of Report | 2009-04-23 |
| Date Mfgr Received | 2009-03-11 |
| Date Added to Maude | 2009-06-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 9458809008 |
| Manufacturer Phone | 9257308272 |
| Manufacturer G1 | ROCHE APPLIED SCIENCE |
| Manufacturer Street | NONNENWALD 2 |
| 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 | 2009-04-06 |
| Catalog Number | 03610179001 |
| Lot Number | 14674120 |
| Device Expiration Date | 2009-12-31 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Address | NONNENWALD 2 PEMZBERG, 82377 GM 82377 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-06 |