MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-06-12 for VERIGENE F2 NUCLEIC ACID TEST 10000002; 10000004 20-005-007 manufactured by Nanosphere Inc.(nsph).
[18058179]
(b)(6) 2013: a call was received by (b)(6) from the hospital reporting a discrepancy between test results obtained for pt a using the verigene system (verigene reader 10-0000-02, verigene processor 10-0000-04, and the verigene f2 nucleic acid test 20-005-007. On (b)(6) 2010, a dna sample from pt a was tested at the hospital using the verigene test, which yielded an f2 "wild type" result. However, new samples of pt a's extracted dna were retested by the hospital on 4 separate occasions approx 2. 5 years later ((b)(6) 2013) using the verigene f5/f2 nucleic acid test (20-005-009) and yielded f2 "heterozygous" and f5 "wild type" results all 4 times. (b)(6) 2013: further information was received by (b)(6) from the hospital that in 2010, pt a was diagnosed with thrombophilia and was being treated with a regimen of anticoagulants for an embolism caused by a blood clot. Furthermore, it was stated by the initial reporter of this event that the f2 "wild type" verigene result may have influenced the decision of the physician to discontinue the previously prescribed anticoagulant medication after the blood clot was resolved. As reported by the hospital, pt a then experienced a second pulmonary embolism on or about (b)(6) 2013, which the pt survived, at which time pt a's dna was retested by the hospital using the verigene f5/f2 nucleic acid test. Therefore, it was perceived by the hospital that the f2 "wild type" result generated in 2010 was incorrect and the f2 "heterozygous" results obtained in 2013 for pt a were correct, and that the presumed incorrect result may have indirectly contributed to pt a's second pulmonary embolism.
Patient Sequence No: 1, Text Type: D, B5
[18322037]
The verigene f2 nucleic acid test is an ivd for the detection of a single point mutation of the human factor ii gene in pts suspected of thrombophilia from an isolated genomic dna sample. A person with a f2 heterozygous genotype is at a 2-4 fold increased risk of a venous thrombosis as compared to a person with a f2 wild type genotype. The prevalence of a f2 mutant in the general population is about 2%. It is clearly stated in the product labeling that f2 genetic information should not be the sole determinant to diagnose thrombophilia. Lot 050110007a utilized for pt a testing on (b)(6) 2010 expired on 11/01/2010. There is no material for lot 050110007a available for eval or investigation; however, the test results and associated raw data used by the verigene system to calculate test results are available. No other complaints have been received by the mfr regarding f2 discrepant results using verigene f2 nucleic acid test cartridge lot 050110007a. (b)(4). The hospital testing of pt a dna in 2010 and 2013 was performed with verigene tests having different part numbers (20-005-007 in 2010, 20-005-009 in 2013); however, both tests are materially identical in form, function, and design with regard to the detection of f2 variants. The information compiled from the mfr's internal investigation indicates that the test yielded a discordant result on (b)(6) 2010 relative to repeated subsequent testing, implying the initial result was incorrect and suggesting a device malfunction. However, presuming the medical information provided by the hospital is accurate, the test was used in a manner consistent with its fda-cleared labeling (i. E. "off-label"). By design, the verigene f2 test is a risk management tool which determines the genetic/inherited pre-disposition of an individual toward thrombophilia, and is not to be used alone to diagnosed thrombophilia. The recent adverse clinical event for a pt previously diagnosed with thrombophilia is not directly related to the perceived malfunction of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006028115-2013-00001 |
| MDR Report Key | 3177067 |
| Report Source | 06 |
| Date Received | 2013-06-12 |
| Date of Report | 2013-05-13 |
| Date of Event | 2013-03-14 |
| Date Mfgr Received | 2013-05-13 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2013-06-24 |
| 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 Street | 4088 COMMERCIAL AVENUE |
| Manufacturer City | NORTHBROOK IL 60062 |
| Manufacturer Country | US |
| Manufacturer Postal | 60062 |
| Manufacturer Phone | 8474009000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERIGENE F2 NUCLEIC ACID TEST |
| Generic Name | F2 GENETIC TEST |
| Product Code | NPQ |
| Date Received | 2013-06-12 |
| Model Number | 10000002; 10000004 |
| Catalog Number | 20-005-007 |
| Lot Number | 0501100007A |
| Device Expiration Date | 2010-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NANOSPHERE INC.(NSPH) |
| Manufacturer Address | NORTHBROOK IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-12 |