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 2019-02-21 for ELECSYS ANTI-CCP IMMUNOASSAY E601 05031656190 manufactured by Roche Diagnostics.
[136807567]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[136807568]
The customer stated that they received erroneous results for one patient sample tested with the elecsys anti-ccp assay on a cobas 6000 e 601 module. No erroneous results were reported outside of the laboratory. No units of measure were provided for the anti-ccp assay. The sample was tested three times, resulting with anti-ccp values of 19. 4, 51. 7, and 51. 6. The probe was washed and the sample was repeated two more times, resulting with values of 24. 7 and 44. 7. No adverse events were alleged to have occurred with the patient. The anti-ccp reagent lot number was 368033. The reagent expiration date was asked for, but not provided. Precision studies were performed. The field service engineer changed the measuring cells of the analyzer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-00733 |
| MDR Report Key | 8358791 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-02-21 |
| Date of Report | 2019-07-10 |
| Date of Event | 2019-02-07 |
| Date Mfgr Received | 2019-02-07 |
| Date Added to Maude | 2019-02-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ELECSYS ANTI-CCP IMMUNOASSAY |
| Generic Name | ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) |
| Product Code | NHX |
| Date Received | 2019-02-21 |
| Model Number | E601 |
| Catalog Number | 05031656190 |
| Lot Number | 368033 |
| Device Expiration Date | 2019-06-30 |
| 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 | 2019-02-21 |