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 2017-12-06 for ELECSYS CA 15-3 II ASSAY 03045838122 manufactured by Roche Diagnostics.
[95078283]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[95078284]
The customer complained of discrepant high results for 3 patient samples tested for elecsys ca 15-3 ii (ca15-3 ii) assay on a cobas 8000 e 602 module with a serial number of (b)(4). On (b)(6) 2017 a field service representative received a set of ca15-3 ii reagent from the customer where the magnetic particles had adhered to the lid of the reagent. On (b)(6) 2017 the customer obtained a calibration for ca15-3 ii that was on the low side (calibration factor of 1. 00). On (b)(6) 2017 the customer tried performing a calibration for a new set of ca15-3 ii reagent but received errors due to differences from previous calibration (calibration factor greater than 1. 2). A field service representative visited the customer and a new ca15-3ii reagent set was calibrated without error (calibration factor of 1. 57) and the control results were normal. The customer decided to repeat patient samples that were near the cutoff and that was when the discrepant results were obtained for 3 patient samples. For patient #1 the initial ca15-3 ii was 29. 3 u/ml with a repeat result of 18. 33 u/ml. For patient #2 the initial ca15-3 ii was 32. 7 u/ml with a repeat result of 19. 7 u/ml. For patient #3 the initial ca15-3 ii was 43. 7 u/ml with a repeat result of 27. 14 u/ml. The initial ca15-3 ii results were reported outside of the laboratory and corrected reports had to issued. There was no allegation of an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02858 |
| MDR Report Key | 7087199 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-06 |
| Date of Report | 2018-03-05 |
| Date of Event | 2017-11-22 |
| Date Mfgr Received | 2017-11-22 |
| Date Added to Maude | 2017-12-06 |
| 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 | 2017-12-06 |
| Model Number | NA |
| Catalog Number | 03045838122 |
| Lot Number | 20990003 |
| ID Number | NA |
| Device Expiration Date | 2018-05-31 |
| 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 | 2017-12-06 |