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 2018-02-12 for ELECSYS BRAHMS PCT E801 07301715190 manufactured by Roche Diagnostics.
[100260026]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[100260027]
The customer received questionable high pct brahms (roche) elecsys e2g (procalcitonin) results during correlation testing for a new cobas 8000 e 801 module. The samples were initially tested (b)(6) 2018 on a cobas 8000 e 801 module and the results were reported outside of the laboratory. On (b)(6) 2018, the samples were repeated on a cobas e 411 immunoassay analyzer and two cobas 8000 e 801 modules. The repeat results from the cobas e 411 immunoassay analyzer were believed to be correct. There was no allegation of an adverse event. The reagent lot number and expiration date were requested but were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00399 |
| MDR Report Key | 7263126 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-12 |
| Date of Report | 2018-03-19 |
| Date of Event | 2018-01-04 |
| Date Mfgr Received | 2018-01-25 |
| Date Added to Maude | 2018-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | RES 79462 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECSYS BRAHMS PCT |
| Generic Name | DEVICE TO DETECT AND MEASURE PROCALCITONIN (PCT) IN HUMAN CLINICAL SPECIMENS |
| Product Code | PMT |
| Date Received | 2018-02-12 |
| Model Number | E801 |
| Catalog Number | 07301715190 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-12 |