MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-03-14 for ELECSYS CA 15-3 II ASSAY 03045838122 manufactured by Roche Diagnostics.
[69954031]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[69954032]
The customer received questionable elecsys ca 15-3 ii assay results for several samples for one patient when compared to the results from an architect analyzer. Information about the analyzer used was requested but was not provided. The result of 25. 0 from (b)(6) 2017 was reported to the physician. It was unknown which results were correct for the patient. The patient was not adversely affected. The customer performed dilutions to rule out a hook effect: initial result: 30. 37 ui/ml. Diluted at 5:15 (manual): 82. 65 ui/ml. Diluted at 1:10 (instrument): 106. 4 ui/ml. Possible reasons for difference in the results include the use of different ca15-3 antibodies in the different assays, the different antibodies could recognize different parts of the molecule, antigen heterogeneity, the lack of an international standard for ca15-3, and the different assay formats.
Patient Sequence No: 1, Text Type: D, B5
[72896472]
Samples from the patient were submitted for investigation and were tested by a third party method. The results from the abbott ca 15-3 assay were confirmed.
Patient Sequence No: 1, Text Type: N, H10
[76647672]
As part of the investigation, the samples were tested on a cobas 6000 e 601 module and the results were verified. A specific root cause could not be identified. There was no evidence of an interfering substance or hama interference. Product labeling for the assay documents different results can be found for ca 15-3 when using different methods.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00555 |
| MDR Report Key | 6403544 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-14 |
| Date of Report | 2017-05-22 |
| Date of Event | 2016-08-23 |
| Date Mfgr Received | 2017-02-27 |
| Date Added to Maude | 2017-03-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECSYS CA 15-3 II ASSAY |
| Generic Name | TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM |
| Product Code | MOI |
| Date Received | 2017-03-14 |
| Model Number | NA |
| Catalog Number | 03045838122 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-14 |