MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-07-06 for FACTOR V LEIDEN KIT 03610179001 manufactured by Roche Diagnostics Gmbh.
[1409487]
A customer site released test results from four invalid factor v leiden kit (for use with the lightcycler 2. 0 instrument) test runs. The customer specified that they review the growth curves prior to releasing test results. As per the product labeling, the test run should have been invalidated and repeated. It is unknown whether any of the invalid test results were inaccurate and/or lead to an incorrect patient treatment decision/change.
Patient Sequence No: 1, Text Type: D, B5
[8601554]
As per the product labeling, customers are instructed that negative and positive controls must be included with each test run. If either control is invalid, the customer must repeat the entire process (specimen and control preparation, amplification and detection). As reported by the customer, patient results that were generated within a test run that contained an invalid positive control were reported. This is an off-label practice that might result in the release of erroneous, but believable, results. In addition to the labeling within the package insert, a product bulletin ((b)(4)) was made available (b)(4) to reaffirm that test results must not be reported if the test run is invalid. This issue does not represent a product malfunction as the product labeling provides clear and sufficient instructions for performing the test. Additionally, there was no report of a death and/or serious injury as a result of the customer's off-label practice. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00031 |
| MDR Report Key | 1746182 |
| Report Source | 05 |
| Date Received | 2010-07-06 |
| Date of Report | 2010-06-07 |
| Date of Event | 2010-06-07 |
| Date Mfgr Received | 2010-06-07 |
| Date Added to Maude | 2012-03-14 |
| 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 | VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202S |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | NONNENWAID 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 | TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR |
| Product Code | NPQ |
| Date Received | 2010-07-06 |
| Catalog Number | 03610179001 |
| Lot Number | 11509420 |
| Device Expiration Date | 2011-04-30 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Address | NONNENWAID 2 PENZBURG, 82377 GM 82377 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-06 |