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 2017-06-08 for ELECSYS CA 15-3 II ASSAY 03045838122 manufactured by Roche Diagnostics.
[77420875]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[77420876]
The customer received questionable high ca 15-3 results for two patient samples where various scans on the patients were negative. Of the data provided, only one patient was tested with the elecsys ca 15-3 ii assay. The patient had breast cancer in 2010 treated by surgery, radiotherapy, and hormone therapy and was monitored for ca 15-3 using the kryptor-brahms method. On (b)(6) 2015, the ca 15-3 result was 30. 9 ku /l. The breast mri was normal and the patient was well. On (b)(6) 2015, the ca 15-3 result was 32. 8 ku /l. In (b)(6) 2015, the patient had a tep that was a normal scan. On (b)(6) 2016, the ca 15-3 result was 97. 8 ku /l, which triggered a new pet scan that showed nothing. In (b)(6) 2017, the patient had a bone scintigraphy with nothing to report. On (b)(6) 2017, the ca 15-3 result was 260. 5 ku /l. As the ca 15-3 results increased but many imaging tests were negative, the customer suspected interference. Dilutions of the samples were performed and did not change the results. On (b)(6) 2017, two of the samples were repeated using the elecsys ca 15-3 ii assay and a cobas 6000 e 601 module. The serial number of the analyzer was requested, but it was not provided. The sample from (b)(6) 2017 had a result of 300. 0 ku/l with a data flag and 280. 1 ku/l with a 1:10 dilution. The sample from (b)(6) 2016 had a result of 113. 4 ku/l and 111. 2 ku/l with a 1:10 dilution. Testing using an hbt tube was negative. The presence of rheumatoid factors (igm and iga) was found to be negative. All of the results were reported outside the laboratory. There was no allegation of an adverse event.
Patient Sequence No: 1, Text Type: D, B5
[132596111]
Samples from the patient were submitted for investigation. No interference could be detected in the samples. The results obtained by the customer were considered to be correct and no general reagent issue was suspected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01178 |
| MDR Report Key | 6622157 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-08 |
| Date of Report | 2017-07-25 |
| Date of Event | 2017-02-09 |
| Date Mfgr Received | 2017-05-23 |
| Date Added to Maude | 2017-06-08 |
| 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 | 2017-06-08 |
| Model Number | NA |
| Catalog Number | 03045838122 |
| Lot Number | 192171 |
| 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 | 2017-06-08 |