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 2017-04-14 for PROBNP II, N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE 04842464190 manufactured by Roche Diagnostics.
[72883770]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[72883771]
The customer questioned the difference in results between the elecsys probnp ii immunoassay and another bnp assay for one patient. The patient was moved from the pediatric department to a cardiovascular department. The cardiovascular physician tested the patient's probnp and the result was < 10 pg/ml. The result for the bnp assay was >800 pg/ml from the same sample. The physician checked the medical history for the patient and found the result for the bnp assay more closely matched the clinical picture for the patient. He also found that the discrepancy between the probnp and bnp results has been ongoing for five years for this patient. There was no allegation of an adverse event. The customer used a cobas 8000 e 602 module. The serial number was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5
[79156341]
Sample from the patient was submitted for investigation and the customer? S result of < 10 pg/ml was confirmed. Two point mutations (r72h and e69d) in the epitope of the detection antibody were suspected. Testing with the probnp ii reagent supplemented with additional detection antibodies for these mutations showed that the bnp in the sample contained the r72h mutation. Therefore, it is not detected by the elecsys probnp ii immunoassay. This type of point mutation is extremely rare and has only been found in complaint samples from (b)(6). A disclaimer was added to product labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00788 |
| MDR Report Key | 6494123 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-14 |
| Date of Report | 2017-06-12 |
| Date of Event | 2017-03-31 |
| Date Mfgr Received | 2017-03-31 |
| Date Added to Maude | 2017-04-14 |
| 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 | 2017-04-14 |
| 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 | 2017-04-14 |