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 2017-06-01 for ELECSYS BRAHMS PCT 05056888200 manufactured by Roche Diagnostics.
[76429010]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[76429011]
The customer stated that they received erroneous results for one patient sample tested for elecsys brahms pct (pct) on a cobas e 411 immunoassay analyzer (e411). It was asked, but it is not known if an erroneous result was reported outside of the laboratory. The sample initially resulted as > 100 ng/ml. The sample was diluted x10 and repeated three times, resulting as 5. 8 ng/ml, 5. 8 ng/ml, and 5. 5 ng/ml. The sample was repeated on (b)(6) 2017, resulting as 80. 64 ng/ml. The sample was also diluted x10 and repeated on (b)(6) 2017, resulting as 5. 8 ng/ml. No adverse events were alleged to have occurred with the patient. The e411 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[78605247]
An update of the repeat results that were obtained at the customer site was provided. The sample was provided for investigation, where it was tested on a cobas e 411 immunoassay analyzer. The sample was measured without dilution and after dilution with both multiassay diluent and pct negative patient serum. The e411 analyzer used for investigation was serial number (b)(4). Pct reagent lot number 203580, with an expiration date of april 2018 was used on this analyzer. The customer results could not be reproduced. The results of the diluted sample obtained during investigations was much higher than those obtained by the customer. The reason why the customer obtained much lower results in dilutions must be related to an unknown local issue within the customer lab. Per product labeling, only samples with results that are outside of the measuring range (>100 ng/ml) should be diluted. The low recovery with diluted sample measurements in the investigation can be attributed to dilutions performed outside of product labeling recommendations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01120 |
| MDR Report Key | 6604367 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-01 |
| Date of Report | 2017-06-27 |
| Date of Event | 2017-05-14 |
| Date Mfgr Received | 2017-05-15 |
| Date Added to Maude | 2017-06-01 |
| 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 | 2017-06-01 |
| Model Number | NA |
| Catalog Number | 05056888200 |
| Lot Number | 203580 |
| 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 | 2017-06-01 |