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 2019-05-24 for ELECSYS ANTI-CCP IMMUNOASSAY 05031656190 manufactured by Roche Diagnostics.
[146070655]
This event occurred in (b)(6). The customer submitted 7 patient samples for investigation. The samples were tested with anti-ccp reagent lots 389152 and 400794 on an e602 module at the investigation site. The investigation was able to reproduce the customer's issue. Six of the seven patient samples showed higher results with reagent lot 389152 compared to reagent lot 400794.
Patient Sequence No: 1, Text Type: N, H10
[146070656]
The initial reporter complained of a high frequency of positive results for patients tested for elecsys anti-ccp immunoassay (anti-ccp) on a cobas 8000 e 602 module. The customer noticed the elevated frequency of positive results in the range of 40 - 60 u/ml since beginning to use anti-ccp reagent lot 389152. The customer provided examples for 3 patient samples: patient 1 had a result of 42 u/ml on the e602 module. On (b)(6) 2019 patient 2 (female with date of birth of (b)(6)) had a result of 48 u/ml on the e602 module. On (b)(6) 2019 patient 3 (male with a date of birth of (b)(6)) had a result of 51 u/ml on the e602 module. The initial results were reported outside of the laboratory where repeat testing was requested. The 3 patient samples were repeated on the e602 module and the results were reproducible. The 3 patient samples were repeated in an external laboratory using the abbott architect method and the results for all 3 patient samples were < 10 u/ml. 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 | 1823260-2019-01942 |
| MDR Report Key | 8640162 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-24 |
| Date of Report | 2019-09-05 |
| Date of Event | 2019-04-17 |
| Date Mfgr Received | 2019-05-07 |
| Date Added to Maude | 2019-05-24 |
| 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 | 1823260-07/16/19-007-C |
| 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 | 2019-05-24 |
| Model Number | NA |
| Catalog Number | 05031656190 |
| Lot Number | 38915201 |
| Device Expiration Date | 2019-09-30 |
| 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 | 2019-05-24 |