MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-03-22 for COBAS AMPLICOR CT/NG TEST 20757497122 manufactured by Roche Molecular Systems.
[3316089]
A customer site in united states reported that they received discrepant (b)(6) results when using the cobas amplicor ct/ng test. The customer site protocol is to repeat test all (b)(6) results in duplicate, which is an off-label practice. As per product labeling, a valid result should be reported and any additional testing should be performed with an alternate method.. The original (b)(6) result on (b)(6) 2013 was (b)(6). The sample was repeated on (b)(6) 2013 and was (b)(6). The sample was again repeated on (b)(6) 2013 and generated a grey zone result. It is not known what result was reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
[10652217]
Result - investigative testing reproduced customer's allegation of discrepant (b)(6) results generated. Conclusion: operational context caused or contributed to event. The customer generated discrepant (b)(6) results for one sample- one (b)(6) result, one (b)(6) result and one grey zone result. Investigative testing for the sample in question was run in triplicate and generated (b)(6) results. Kit retain testing of the complaint kit batch generated valid results that met specification. It is possible that the cause of the discrepant results is due to an unknown sample specific issue, but this cannot be definitively confirmed. As the retain kit testing met specification, there is no indication of a product non-conformance. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2013-00004 |
| MDR Report Key | 3017315 |
| Report Source | 05 |
| Date Received | 2013-03-22 |
| Date of Report | 2013-02-21 |
| Date of Event | 2013-02-19 |
| Device Manufacturer Date | 2011-02-16 |
| Date Added to Maude | 2013-05-23 |
| 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, CHLAMYDIA |
| Product Code | MKZ |
| Date Received | 2013-03-22 |
| Catalog Number | 20757497122 |
| Lot Number | R10705 |
| Device Expiration Date | 2014-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2013-03-22 |