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 2017-12-07 for ELECSYS BRAHMS PCT 05056888200 manufactured by Roche Diagnostics.
[95736813]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[95736814]
The customer received questionable elecsys brahms pct (procalcitonin) results from a cobas 8000 e801 module. The analyzer serial number was requested but was not provided. The customer said the issue occurred with 10 out of 1000 samples per month. The customer used serum, edta plasma, and citrate plasma from the patient and retested the samples after several hours. The customer also tested the samples by sqh method and retested after addition to a coagulation acceleration tube (thrombin + heparin neutralizing agent). The customer also performed experiments of mixing several samples which showed procalcitonin increase. No erroneous results were reported outside of the laboratory. There was no allegation of an adverse event. The customer speculated that anti-procalcitonin antibody may be causing agglutination with serums contain high micro-fibrin.
Patient Sequence No: 1, Text Type: D, B5
[117890470]
The investigation was unable to find a definitive root cause. Roche has informed the customer of possible discrepancies with procalcitonin results between the cobas e801 and other roche analyzers and advised the customer to discontinue testing on the cobas e801. A recall was initiated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-02870 |
| MDR Report Key | 7095868 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-07 |
| Date of Report | 2018-04-02 |
| Date of Event | 2017-11-16 |
| Date Mfgr Received | 2017-11-17 |
| Date Added to Maude | 2017-12-07 |
| 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 | 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 | 2017-12-07 |
| Model Number | NA |
| Catalog Number | 05056888200 |
| Lot Number | 204084 |
| 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 | 2017-12-07 |