MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-15 for COBAS AMPLICOR ANALYZER 21045156001 manufactured by Roche Diagnostics Ltd..
[4525852]
A customer in the united states filed a complaint case as it was identified that the resuspension tip tubing on the cobas amplicor analyzer was accidentally inverted during periodic maintenance of their system, which was performed by the local field service engineer. This inversion was identified as the customer's cobas amplicor analyzer was leaking when they were performing cobas ampliscreen hcv test, v2. 0 runs on the system. Upon identification of the issue, the customer's system was repaired and the resuspension tip tubing was re-installed appropriately by the local field service engineer. All donor samples that generated non-reactive hcv results with the cobas ampliscreen hcv test, v2. 0 during the timeframe of when the resuspension tip tubing was inverted ((b)(6) 2014) were subjected to repeat testing; a total of 30 donor samples were repeated tested. One (1) donor out of the 30 donor samples tested generated discrepant results between initial testing (non-reactive hcv result) and repeat testing (reactive hcv result); the same lots of cobas ampliscreen hcv test, v2. 0 were used for both test runs. The serology result for this donor could not be confirmed. It is unknown if the initial non-reactive hcv result was reported and if the donor sample was released; this information could not be confirmed as the customer has not been willing to provide additional details surrounding this situation. The true diagnosis of the donor is unknown. The customer did not repeat test those donor samples that generated reactive hcv results as these results were aligned with positive serology results. This mdr is specific to the cobas amplicor analyzer as the inversion of the resuspension tip tubing could potentially result in inadequate dispension of wash reagent to the reaction cups used during the viral detection.
Patient Sequence No: 1, Text Type: D, B5
[11890376]
Result: failure to service/maintain according to the manufacturer's recommendation. Conclusion: device failure related to maintenance 24 off label, unapproved, or contradicted use. The investigation of this issue indicated that the local field service engineer had inverted the resuspension tip tubing during periodic maintenance of the customer's cobas amplicor analyzer; the service documentation does provide adequate instruction on how to replace resuspension tip tubing and specifies that the engineer must verify that the "fittings correspond to the correct clips at the wash arm" as well as provides an image to assist with this verification. The inversion of the resuspension tip tubing could potentially result in inadequate dispension of wash reagent to the reaction cups used during viral detection; inappropriate washing may impact test results, and this has not been evaluated by roche nor confirmed for the current case or for the donor sample that generated discrepant hcv results as the donor sample was not returned for further evaluation. There is no indication of a product issue with the cobas ampliscreen hcv test, v2. 0 kits indicated to be used at the site as they have been determined to be within specification and performing as intended. It is unknown if the initial non-reactive hcv result was reported and if the donor sample was released; this information could not be confirmed as the customer has not been willing to provide additional details surrounding this situation. The true diagnosis of the donor is unknown. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[34907905]
Within the initial mdr 2243471-2014-00015 filed, it was indicated that it was unknown whether the sample that generated the discrepant results was released for transfusion. It was later clarified that the sample was appropriately discarded and not transfused. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2014-00015 |
| MDR Report Key | 3813623 |
| Report Source | 05 |
| Date Received | 2014-05-15 |
| Date of Report | 2014-05-19 |
| Date of Event | 2014-04-07 |
| Date Mfgr Received | 2014-05-19 |
| Date Added to Maude | 2014-06-26 |
| 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 |
| Manufacturer G1 | ROCHE DIAGNOSTICS LTD. |
| Manufacturer Street | FORRENSTRASSE |
| Manufacturer City | ROTKREUZ, CH-6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLICOR ANALYZER |
| Generic Name | ANALYZER, CHEMISTY, MICRO, FOR CLINICAL USE |
| Product Code | JJF |
| Date Received | 2014-05-15 |
| Catalog Number | 21045156001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS LTD. |
| Manufacturer Address | FORRENSTRASSE ROTKREUZ, CH-6343 SZ CH-6343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-15 |