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 2018-01-05 for COBAS E-ELECSYS ANTI-CCP 05031656190 manufactured by Roche Diagnostics.
[97478481]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[97478482]
The customer received questionable high elecsys anti-ccp immunoassay results for two samples from one patient. The results from cobas e 411 immunoassay analyzer serial number (b)(4) were 208 u/ml and 233 u/ml. These results were reported to the clinician. The samples were then tested by elisa method and the result for both samples were negative (0. 1 ratio with cutoff=1). No specific results were provided. There was no allegation of an adverse event. The customer checked the results for other patients by both methods and all compared. The calibration and qc data was found to be acceptable. One of the samples was tested on a cobas 8000 e 602 module and the result was 217 u/ml. Product labeling for the assay documents that anti-ccp values generated by different technologies can vary.
Patient Sequence No: 1, Text Type: D, B5
[131701456]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. As two samples from the same patient generated comparable high values and as a value in the same range was generated with a second roche analyzer, the results were believed to be correct. From the information provided, a general reagent issue could most likely be excluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-00076 |
| MDR Report Key | 7167381 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-05 |
| Date of Report | 2018-01-29 |
| Date of Event | 2017-12-13 |
| Date Mfgr Received | 2017-12-15 |
| Date Added to Maude | 2018-01-05 |
| 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 | COBAS E-ELECSYS ANTI-CCP |
| Generic Name | ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) |
| Product Code | NHX |
| Date Received | 2018-01-05 |
| Model Number | NA |
| Catalog Number | 05031656190 |
| Lot Number | 25525501 |
| ID Number | NA |
| Device Expiration Date | 2018-01-31 |
| 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 | 2018-01-05 |