MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-11-20 for LIGHTCYCLER FACTOR V LEIDEN KIT 03610179001 manufactured by Roche Diagnostics Gmbh.
[1811286]
A customer site in (b)(6) reported that discrepant results were generated with the lightcycler factor v leiden kit. Specifically, the customer indicated that the initial specimen, which was collected from a child, was detected as homozygous mutant on (b)(6) 2010. It was determined that a homozygous mutant genotype was not plausible as the child's parents were heterozygous and wildtype. Therefore, a second specimen was collected and tested (on (b)(6) 2010) in duplicate with the lightcycler factor v leiden kit. Both replicates from the repeat test were heterozygous. There was no patient harm as, prior to any patient medical management decisions, it was identified that the original test result was incorrect due to the parents' genotypes.
Patient Sequence No: 1, Text Type: D, B5
[8979610]
An analysis of the customer data and a review of the complaint history for this issue were performed. The allegation reported by the customer was investigated; however, neither a cause for the reported event nor a product non-conformance / malfunction was identified. A review of the customer data indicated that the software performed as intended and the kit controls were comparable to quality control release testing. Furthermore, a complaint history analysis revealed that no previous complaints have been filed related to this reported issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00044 |
| MDR Report Key | 1903908 |
| Report Source | 01,05 |
| Date Received | 2010-11-20 |
| Date of Report | 2010-10-21 |
| Date of Event | 2010-09-20 |
| Date Mfgr Received | 2010-10-21 |
| Date Added to Maude | 2012-03-15 |
| 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 | 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 | LIGHTCYCLER FACTOR V LEIDEN KIT |
| Generic Name | TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR; 864.7280 |
| Product Code | NPQ |
| Date Received | 2010-11-20 |
| Catalog Number | 03610179001 |
| Lot Number | 11509520 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2010-11-20 |