MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-21 for ELECSYS CA 15-3 03045838122 manufactured by Roche Diagnostics.
[41059727]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[41059728]
The customer complained of erroneous results for 1 patient sample tested for cancer antigen 15-3 (ca 15-3 ii) and carbohydrate antigen 19-9 (ca 19-9). The erroneous results were reported outside of the laboratory. This medwatch will cover ca 15-3 ii. Refer to medwatch with (b)(6) for information on the ca 19-9 erroneous results. The initial ca 15-3 result from the e601 analyzer was 289. 4 u/ml. The sample was repeated on the e601 analyzer on (b)(6) 2016 and the result was 276 u/ml. The sample was repeated at a different laboratory on an abbott instrument and the result was 193. 7 (unit of measure not provided). The initial ca 19-9 result from the e601 analyzer was 393. 54 u/ml. The sample was repeated on the e601 analyzer on (b)(6) 2016 and the result was 391. 7 u/ml. The sample was repeated at a different laboratory on an abbott instrument and the result was 962. 3 (unit of measure not provided). It is not known if an adverse event occurred. No adverse event was reported. The e601 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[42628117]
A specific root cause could not be identified. It was noted that the customer now believes that the roche results were correct based on an external quality survey that produced optimal results. No further information will be provided by the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00335 |
| MDR Report Key | 5514280 |
| Date Received | 2016-03-21 |
| Date of Report | 2016-04-13 |
| Date of Event | 2016-02-29 |
| Date Mfgr Received | 2016-03-03 |
| Date Added to Maude | 2016-03-21 |
| 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 |
| Generic Name | TEST, CANCER ANTIGEN (CA 15-3 II) |
| Product Code | MOI |
| Date Received | 2016-03-21 |
| 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 | 2016-03-21 |