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 2016-09-15 for COBAS E-ELECSYS ANTI-CCP 05031656190 manufactured by Roche Diagnostics.
[54894089]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[54894090]
The customer received questionable elecsys anti-ccp immunoassay results for one patient sample from a cobas e602 analyzer (unknown serial number) and another unknown roche analyzer. The initial result was 197 u/ml (positive). The sample was tested on another roche system and the result was positive. No specific data was provided. The result on an abbott architect on (b)(6) 2016 was 6. 0 u/ml (negative). The result with elisa (euroimmun) on 07/08/2016 had been <5 u/ml (negative). The result with thermofisher (elia) was negative. No specific data or date of testing was provided. Information concerning if the erroneous result was reported the patient and/or medical personnel treating the patient was requested, but it was unknown. The patient was not adversely affected. As no sample material was available for further investigation, a specific root cause could not be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2016-01386 |
| MDR Report Key | 5953335 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-15 |
| Date of Report | 2016-09-15 |
| Date of Event | 2016-07-12 |
| Date Mfgr Received | 2016-08-25 |
| Date Added to Maude | 2016-09-15 |
| 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 | 2016-09-15 |
| Model Number | NA |
| Catalog Number | 05031656190 |
| Lot Number | 13592000 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-09-15 |