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 2018-05-14 for ELECSYS ANTI-CCP IMMUNOASSAY 05031656160 manufactured by Roche Diagnostics.
[108253135]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[108253136]
The customer stated that they received erroneous results for three patient samples tested for the elecsys anti-ccp immunoassay (anti-ccp) on a cobas e 411 immunoassay analyzer (e411) and a cobas 6000 e 601 module (e601) used at a second site. It was asked, but it is not known if any erroneous results were reported outside of the laboratory. The first sample initially resulted with an anti-ccp value of 34. 7 u/ml (reference range = < 17 u/ml) on the e411 analyzer. The sample was repeated in another laboratory using an unknown test method, resulting as 0. 4 u/ml (reference range = 0 - 5 u/ml). The second sample initially resulted with an anti-ccp value of > 500 u/ml (reference range = < 17 u/ml) on the e411 analyzer. The sample was repeated on the e601 analyzer at the second site, resulting as 495 u/ml (reference range = < 17 u/ml). The sample was repeated in another laboratory using an unknown test method, resulting as 240 u/ml (reference range = 0 - 5 u/ml). The third sample initially resulted with an anti-ccp value of 41. 7 u/ml (reference range = < 17 u/ml) on the e411 analyzer. The sample was repeated on the e601 analyzer at the second site, resulting as 44 u/ml (reference range = < 17 u/ml). The sample was repeated in another laboratory using an unknown test method, resulting as 1. 2 u/ml (reference range = 0 - 5 u/ml). No adverse events were alleged to have occurred with the patients. The e411 analyzer serial number is (b)(4). The serial number of the e601 analyzer was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01470 |
| MDR Report Key | 7510063 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-14 |
| Date of Report | 2018-06-20 |
| Date of Event | 2018-04-26 |
| Date Mfgr Received | 2018-04-26 |
| Date Added to Maude | 2018-05-14 |
| 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 | 2018-05-14 |
| Model Number | NA |
| Catalog Number | 05031656160 |
| Lot Number | 293756 |
| ID Number | NA |
| Device Expiration Date | 2018-06-30 |
| 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 | 2018-05-14 |