MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-06-02 for FACTOR II (PROTHOMBIN) G20210A TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT 03610195001 manufactured by Roche Diagnostics Gmbh.
[1616051]
A customer site in (b)(6) reported that a patient specimen, which was tested with the factor ii (prothrombin) g20210a kit, was incorrectly designated as "wildtype" by the lightcycler software 4. 05 / factor ii (prothrombin) g20210a macro. The customer indicated that, based on the patient specimen's growth curve, the patient specimen should have been called "unknown. " the customer later repeat tested the patient specimen and the patient specimen was called "unknown. " although it was not specified by the customer, based on the available information it does not appear as though the patient specimen was reported to the treating physician as "wildtype. "
Patient Sequence No: 1, Text Type: D, B5
[8626908]
The investigation into this issue is ongoing. Preliminary analysis indicates that the lightcycler software 4. 05 / factor ii (prothrombin) g20210a macro properly called the patient specimen as "wildtype" based on the patient specimen's growth curve. A more detailed analysis is ongoing and the investigation conclusions will be reported through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00028 |
| MDR Report Key | 1705491 |
| Report Source | 05 |
| Date Received | 2010-06-02 |
| Date of Report | 2010-09-23 |
| Date of Event | 2010-05-03 |
| Date Mfgr Received | 2010-09-23 |
| Date Added to Maude | 2011-04-08 |
| 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 II (PROTHOMBIN) G20210A TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT |
| Generic Name | TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR |
| Product Code | NPR |
| Date Received | 2010-06-02 |
| Catalog Number | 03610195001 |
| Lot Number | 11666730 |
| 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 | 2010-06-02 |