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 2015-10-20 for ROCHE ELECSYS ANTI-CCP IMMUNOASSAY 05031656190 manufactured by Roche Diagnostics.
[28805983]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[28805984]
The customer received questionable anti-ccp results for one patient from an unknown roche analyzer. On (b)(6) 2015, the result was 478 u/ml, but the result by stacia, meblux test whose principle was cleia, was negative. Additionally, the patient's rf was negative. It was unclear if this testing was performed with the same sample. On (b)(6) 2015, the result was 453 u/ml, but the result for the same sample with by stacia, meblux test was negative. The rf result was negative and the anti-nuclear antibody (ana) was <40 folds. Information concerning if any erroneous result was reported outside the laboratory was requested, but was not provided. The patient was not adversely affected.
Patient Sequence No: 1, Text Type: D, B5
[33614111]
A specific root cause could not be identified as the sample was not available for further investigation. A possible cause for the issue could have been an interference in the sample.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04357 |
| MDR Report Key | 5162018 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-10-20 |
| Date of Report | 2015-12-16 |
| Date of Event | 2015-06-08 |
| Date Mfgr Received | 2015-10-02 |
| Date Added to Maude | 2015-10-20 |
| 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 | ROCHE ELECSYS ANTI-CCP IMMUNOASSAY |
| Generic Name | ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) |
| Product Code | NHX |
| Date Received | 2015-10-20 |
| Model Number | NA |
| Catalog Number | 05031656190 |
| Lot Number | ASKU |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-20 |