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 2017-09-20 for COBAS E-ELECSYS ANTI-CCP 05031656190 manufactured by Roche Diagnostics.
[88416806]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[88416807]
The customer received questionable high elecsys anti-ccp immunoassay results for one patient compared to other methodologies. On (b)(6) 2017, the anti-ccp result from a cobas 6000 e 601 module was 163. 6 u/ml. Based on this result, the patient was diagnosed with an autoimmune disease. Sample 1 drawn on (b)(6) 2017 was tested on a quantalyser 160 (elisa) on (b)(6) 2017 and had a result of 3. 35 units. This result was believed to be incorrect and the customer asked the patient to repeat the anti-ccp testing. Sample 2 was drawn on (b)(6) 2017. The result from the quantalyser 160 (elisa) on (b)(6) 2017 was 0. 00 units. An aliquot of the same sample was tested on siemens centaur (clia) on (b)(6) 2017 and the result was <0. 40 u/ml. An aliquot of the same sample was tested on a cobas 6000 e 601 module on (b)(6) 2017 and the result was 146. 40 u/ml. The results were reported outside of the laboratory. There was no allegation of an adverse event. The serial numbers of the involved cobas 6000 e 601 modules were requested but were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02022 |
| MDR Report Key | 6878942 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-20 |
| Date of Report | 2017-11-06 |
| Date of Event | 2017-08-25 |
| Date Mfgr Received | 2017-08-29 |
| Date Added to Maude | 2017-09-20 |
| 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 | 2017-09-20 |
| Model Number | NA |
| Catalog Number | 05031656190 |
| Lot Number | 227465 |
| 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 | 2017-09-20 |