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 2017-01-11 for PROBNP II, N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE 04842464190 manufactured by Roche Diagnostics.
[64620106]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[64620107]
The physician complained to the sales representative that the results for 1 patient were continuously negative when tested for elecsys probnp ii immunoassay (probnp ii) between (b)(6) 2016. The erroneous results were reported outside of the laboratory. On (b)(6) 2016 the patient had probnp ii results of <5. 0 pg/ml. All results were reported to the physician who questioned the results and sent the sample from (b)(6) 2016 to an external laboratory to test bnp. The bnp result was 2940 pg/ml. No adverse event occurred. The instrument type and serial number were not provided.
Patient Sequence No: 1, Text Type: D, B5
[65684311]
A company representative visited the physician on 01/18/2017 to discuss obtaining the patient sample for investigation. The physician had performed an internal study and was no longer requesting an investigation of the sample. The physician indicated the patient involved in this event had died. There was no allegation that the death was related to the probnp ii results from the device.
Patient Sequence No: 1, Text Type: N, H10
[69339459]
A specific root cause was not identified for this event. Additional information was requested for investigation but was not provided. Since the sample was not available, the investigation could not be completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00065 |
| MDR Report Key | 6242845 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-11 |
| Date of Report | 2017-03-07 |
| Date of Event | 2016-12-13 |
| Date Mfgr Received | 2016-12-22 |
| Date Added to Maude | 2017-01-11 |
| 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 | PROBNP II, N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE |
| Generic Name | TEST,NATRIURETIC PEPTIDE |
| Product Code | NBC |
| Date Received | 2017-01-11 |
| Model Number | NA |
| Catalog Number | 04842464190 |
| 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 | 2017-01-11 |