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 2018-05-07 for PROBNP II, N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE 04842464190 manufactured by Roche Diagnostics.
[107570071]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[107570072]
The customer received questionable elecsys probnp ii immunoassay results for one patient. The erroneous results were reported outside of the laboratory and were believed to be not high enough by the doctor since the patient was diagnosed with acute coronary heart failure (acute chf). The initial result was 338 pg/ml and the repeat result was 335. 4 pg/ml. As analyte-specific antibodies or an interference was suspected, the customer repeated the sample with dilutions. With a 1:2 dilution, the result was 324. 7 pg/ml. With a 1:10 dilution, the result was 335. 4 pg/ml. There was no allegation of an adverse event. The customer used cobas e 411 immunoassay analyzer serial number (b)(4). As no sample could be provided, further investigation was not possible. The investigation was unable to find a definitive root cause.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01406 |
| MDR Report Key | 7492031 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-07 |
| Date of Report | 2018-05-07 |
| Date of Event | 2018-04-20 |
| Date Mfgr Received | 2018-04-23 |
| Date Added to Maude | 2018-05-07 |
| 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 | 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 | 2018-05-07 |
| Model Number | NA |
| Catalog Number | 04842464190 |
| Lot Number | 29280800 |
| ID Number | NA |
| Device Expiration Date | 2019-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-05-07 |