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 2016-09-27 for COBAS E-ELECSYS ANTI-CCP 05031656190 manufactured by Roche Diagnostics.
[55697750]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[55697751]
The customer received questionable elecsys anti-ccp immunoassay results for one patient when compared to the results from elisa-assay of euroimmun assay and siemens immulite assay. The customer was using cobas e601 analyzer serial number (b)(4). The patient was to take part in a clinical study and was tested for anti-ccp and other study relevant markers. Due to the discrepancy in the anti-ccp results, the patient's participation in the study was in question. The customer wanted confirmation of the results in order to be sure of the "pre-characterization of this patient" for the study. The results from the e601 were 71. 82 u/ml and 71. 76 u/ml (72) (positive) which matched the patient's clinical picture. The result from the siemens assay was 2. 2 u/ml (normal). The result from the elisa assay on 09/03/2016 was 7. 8 u/ml (indeterminate). No adverse event was reported. The medical doctors in charge heavily criticized the elevated result and claimed an assay performance issue. Sample from the patient was submitted for investigation and was tested on a cobas e411 analyzer and an analytical e module analyzer. The results were found comparable to the customer's results and an interfering factor to streptavidin could be excluded. Based on the results, a product problem could not be found.
Patient Sequence No: 1, Text Type: D, B5
[58472045]
Additional information was provided that the patient suffers from rheumatoid arthritis and received "methotrexat treatment" during the time the questionable results were generated.
Patient Sequence No: 1, Text Type: N, H10
[58725210]
Additional information was received that the results were not used for any diagnostic purpose and were used only for testing of patient for participation in the clinical study. The results were not provided to a person making a treatment decision for the patient. The patient was not adversely affected in any way.
Patient Sequence No: 1, Text Type: N, H10
[61328134]
A specific root cause could not be confirmed. From the information provided and the analysis of the sample, a general reagent issue could be excluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01467 |
| MDR Report Key | 5979361 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-27 |
| Date of Report | 2016-12-01 |
| Date of Event | 2016-09-01 |
| Date Mfgr Received | 2016-09-05 |
| Date Added to Maude | 2016-09-27 |
| 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 | 2016-09-27 |
| Model Number | NA |
| Catalog Number | 05031656190 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-09-27 |