MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-01-12 for AMPLICHIP CYP450 TEST 04591402190 manufactured by Roche Molecular Systems.
[1784333]
The customer site in the united states reported that discrepant results were generated when a patient specimen was tested with the amplichip cyp450 test. The complaint states that the issue occurred after the repeat testing of the original sample. According to the customer, originally there was no indication of discrepant results, and the repeat test was done by accident; the customer was unaware they had previously tested the sample. The patient was not harmed as a result of these discrepant test results.
Patient Sequence No: 1, Text Type: D, B5
[8924020]
Investigation into this issue is ongoing, and therefore, no conclusion can be made at this time. Currently roche is waiting for data analysis results. According to the complaint, discrepant results were observed upon retesting a sample, the original results were accepted. Final investigative conclusions will be submitted through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9183965]
Result: unapproved use of device. Conclusion: off-label, unapproved or contraindicated use. During the course of the investigation, it was determined that the customer was performing multiple off-label procedures not specified in the product labeling that could result in sub-optimal performance of the amplichip cyp450 assay. The customer adds blue juice to their samples prior to amplification to visually see their sample in the amplification tray. This may alter the working master mix (mmx) concentration and introduce dye into the pcr reaction. Bromophenol blue or alcohol may interfere with the pcr reaction. The customer vortexes and quick spins their samples at each step of the assay. Enzymes should not be vortexed. The customer stores extracted genomic dna beyond the package insert claims, which are 2-8c for up to one week or frozen at -20c for up to one month with no more than three freeze-thaw cycles. The customer does not check the dna quality as described in the product labeling. Internal testing of retain kit (b)(4) generated valid and acceptable results for the controls and stock dna samples and no discrepant results were generated. No product or batch non-conformance was identified during the course of the investigation. The discrepancies observed by the customer were likely the result of workflow and handling issues. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2011-00003 |
| MDR Report Key | 1959204 |
| Report Source | 05 |
| Date Received | 2011-01-12 |
| Date of Report | 2010-12-13 |
| Date of Event | 2010-12-13 |
| Date Mfgr Received | 2010-12-13 |
| Device Manufacturer Date | 2010-09-30 |
| Date Added to Maude | 2012-05-08 |
| 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 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLICHIP CYP450 TEST |
| Generic Name | DRUG METABOLIZING ENZYME GENOTYPING SYSTEMS |
| Product Code | NTI |
| Date Received | 2011-01-12 |
| Catalog Number | 04591402190 |
| Lot Number | N12803 |
| Device Expiration Date | 2011-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HW 202S BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-12 |