MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-01-31 for COBAS AMPLICOR CT/NG TEST 20759902122 manufactured by Roche Molecular Systems.
[3280467]
A customer from the us filed a complaint alleging that a (b)(6) result was generated for one sample while using the cobas amplicor (b)(6) test for (b)(6). No information regarding the patient was provided. Sample id (b)(4) was initially negative on (b)(6) 2012 and was repeated on (b)(6) 2013 (both results were (b)(6)). The sample type was a male swab. No other test method was used to confirm the results.
Patient Sequence No: 1, Text Type: D, B5
[10374921]
Result: device performed according to specifications conclusion: it cannot be definitively determined what the true cause of the discrepant results is. The sample was sent for investigative testing. Three replicates of the sample were analyzed using the. Cobas amplicor test for (b)(6). One sample was (b)(6), one was negative for (b)(6) and one generated equivocal results. Retain testing of the complaint kit lot met specifications. It is unknown if the patient was symptomatic or asymptomatic. In the procedural limitations section of the test's package insert, it is stated that "although evaluated with urine from females and swabs from asymptomatic males, the cobas amplicor test for (b)(6) had reduced performance and is not recommended for testing female urine specimens or asymptomatic male swab specimens. " as no patient information was provided for the male swab specimen in question, it cannot be determined if this may have played a role in the generation of the discrepant results. In addition, the package insert states "additional testing is recommended in any circumstance when (b)(6) or false negative results could lead to adverse medical, social or psychological consequences. " no additional testing was performed by the customer. It cannot be definitively determined what the true cause of the discrepant results is. Retain testing of the complaint kit lot met specifications. The cause of the discrepant results in this complaint may likely be sample specific. There is no indication of a product non-conformance. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2013-00001 |
| MDR Report Key | 2937854 |
| Report Source | 05 |
| Date Received | 2013-01-31 |
| Date of Report | 2013-01-03 |
| Date of Event | 2012-12-31 |
| Date Mfgr Received | 2013-01-03 |
| Device Manufacturer Date | 2011-02-16 |
| Date Added to Maude | 2013-04-17 |
| 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 | COBAS AMPLICOR CT/NG TEST |
| Generic Name | DNA PROBE, NUCLEIC ACID AMPLIFICATION, NEISSERIA |
| Product Code | LSL |
| Date Received | 2013-01-31 |
| Catalog Number | 20759902122 |
| Lot Number | R02623 |
| Device Expiration Date | 2013-12-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2013-01-31 |