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 2018-05-16 for ELECSYS CA 125 II 11776223190 manufactured by Roche Diagnostics.
[108901785]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[108901786]
The customer questioned high results for 3 patient samples tested for either elecsys ca 19-9 immunoassay (ca 19-9), elecsys ca 125 ii assay (ca 125 ii) or elecsys ca 15-3 ii assay) ca 15-3 ii on a cobas e 411 immunoassay analyzer. The customer provided discrepant results for 2 patient samples tested for either ca 19-9 or ca 125 ii. The customer did not provide any results for the patient tested for ca 15-3 ii. This medwatch will cover ca 125 ii. Refer to medwatch with patient identifier (b)(6) for information on the ca 19-9 results. Patient 1 initial ca 19-9 result on the e411 analyzer was 54. 63 u/ml. The sample was tested in an external laboratory by possibly the abbott method with a result of 27. 9 u/ml. Patient 2 initial ca 125 ii result on the e411 analyzer was 43. 22 u/ml. The sample was tested in an external laboratory by an unknown method with a result of 23. 4 u/ml. The customer stated the results were repeatable on the e411 analyzer but no data was provided. The incorrect results were not reported outside of the laboratory. The customer thinks the lower results from the abbott and other unknown method are correct. There was no allegation that an adverse event occurred. The e411 analyzer serial number was (b)(4). The customer does not run qc on a daily basis, however qc results from the day of the event were ok. The reagent pack for ca 125 ii was first used on (b)(6) 2017 and the last calibration with this pack was on (b)(6) 2018. Calibration was performed 11 weeks after the first use. The stability of the reagent pack according to product labeling is 12 weeks after opening and 6 weeks on the analyzer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01519 |
| MDR Report Key | 7518952 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-16 |
| Date of Report | 2018-06-12 |
| Date of Event | 2018-04-23 |
| Date Mfgr Received | 2018-04-27 |
| Date Added to Maude | 2018-05-16 |
| 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 125 II |
| Generic Name | TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125) |
| Product Code | LTK |
| Date Received | 2018-05-16 |
| Model Number | NA |
| Catalog Number | 11776223190 |
| Lot Number | 25618001 |
| ID Number | NA |
| Device Expiration Date | 2018-10-31 |
| 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 | 2018-05-16 |