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 2016-12-09 for PROBNP II, N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE 04842464190 manufactured by Roche Diagnostics.
[62369662]
Age - the customer states the patient is "(b)(6). " this event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[62369663]
The customer complained of erroneously low results for 1 patient tested for elecsys probnp ii immunoassay (probnp ii). The actual date of event was requested but not provided. The initial probnp ii result was <5 pg/ml on the cobas e 411 immunoassay analyzer. The customer stated this result matched a previous result. The sample was re-centrifuged and the repeat result was <5pg/ml. These results were reported outside of the laboratory where the doctor questioned the results stating they didn? T match the patient? S x-rays. No adverse event occurred. The e411 analyzer serial number was (b)(4). The customer stated that other patient? S samples generate expected results. Calibration and quality controls were acceptable.
Patient Sequence No: 1, Text Type: D, B5
[63276899]
Date of birth and age were updated. The customer stated the patient had a bnp result of 13. 9 pg/ml. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[68488400]
The patient sample was submitted for investigation. The sample was tested and the customer's result of <5 pg/ml was confirmed. Further investigation of the sample showed that the analyte in the sample contains a mutation in the epitope of the detection antibody that causes false negative results for the probnp ii assay. The device did not malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01936 |
| MDR Report Key | 6159090 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-09 |
| Date of Report | 2017-02-14 |
| Date of Event | 2016-11-22 |
| Date Mfgr Received | 2016-11-22 |
| Date Added to Maude | 2016-12-09 |
| 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 | 2016-12-09 |
| Model Number | NA |
| Catalog Number | 04842464190 |
| Lot Number | 168992 |
| ID Number | NA |
| Device Expiration Date | 2017-11-30 |
| 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 | 2016-12-09 |