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 2019-05-22 for ELECSYS ANTI-CCP IMMUNOASSAY 05031656190 manufactured by Roche Diagnostics.
[145750280]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[145750281]
The initial reporter complained of high results for multiple patients tested for elecsys anti-ccp immunoassay (anti-ccp) on a cobas 8000 e 602 module. In (b)(6) 2019 the customer began to use anti-ccp reagent lot 368033 and noticed an abrupt change in the results. The results were reported outside of the laboratory where the rheumatologists complained of a higher than normal "positive" rate and the results did not correspond to the clinical condition for the affected patient. After (b)(6) 2019 the customer noticed that instead of getting "mostly" results of < 8 u/ml and occasional positive results in the 100's u/ml, all anti-ccp results were between 20-60 u/ml. Data for the results for 39 patient samples tested between (b)(6) 2019. None of the patient samples with questionable high anti-ccp results were repeated. There was no allegation that an adverse event occurred. The e602 module serial number was (b)(4). Investigations are ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01906 |
| MDR Report Key | 8631043 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-22 |
| Date of Report | 2019-09-05 |
| Date of Event | 2019-01-24 |
| Date Mfgr Received | 2019-05-01 |
| Date Added to Maude | 2019-05-22 |
| 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 | 2019-05-22 |
| Model Number | NA |
| Catalog Number | 05031656190 |
| Lot Number | 368033 |
| 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 | 2019-05-22 |