MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-28 for ELECSYS BRAHMS PCT 05056888200 manufactured by Roche Diagnostics.
[93611456]
(b)(4). The event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[93611457]
The customer complained of high patient results for 1 patient tested for elecsys brahms pct (pct) on a cobas 8000 e 602 module compared to the results from a lumipulse. The customer complained that the patient? S pct results were not matching the patient? S clinical picture. (b)(4). The erroneous results were not reported outside of the laboratory. There was no allegation of an adverse event. The customer? S e602 module serial number was not provided. The e602 module serial number used at the investigation site was (b)(4). The pct reagent lot used at the investigation site was 159481 with an expiration date of feb-2018. The e411 serial number used at the investigation site was (b)(4). The pct reagent lot information that was used on the e411 at the investigation site was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02751 |
| MDR Report Key | 7062639 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-28 |
| Date of Report | 2018-01-30 |
| Date of Event | 2017-10-06 |
| Date Mfgr Received | 2017-11-10 |
| Date Added to Maude | 2017-11-28 |
| 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 |
| 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 BRAHMS PCT |
| Generic Name | DEVICE TO DETECT AND MEASURE PROCALCITONIN (PCT) IN HUMAN CLINICAL SPECIMENS |
| Product Code | PMT |
| Date Received | 2017-11-28 |
| Model Number | NA |
| Catalog Number | 05056888200 |
| 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 | 2017-11-28 |