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 2018-06-29 for PROBNP II, N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE 04842464190 manufactured by Roche Diagnostics.
[112895766]
Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[112895767]
The customer stated that they received erroneous results for two samples from the same patient tested for the elecsys probnp ii immunoassay (probnp) on the customer's cobas 6000 e 601 module (e601). One additional sample from the same patient had an erroneous probnp result when tested on a cobas 8000 e 602 module (e602) and a cobas e 411 immunoassay analyzer (e411) used for investigation. The erroneous results were reported outside of the laboratory. The patient data suggested that the patient has a mutation of the nt-probnp fragment, which is detected by the probnp assay. The patient had a sample collected and it was tested at another hospital on (b)(6) 2018 with an unknown bnp assay, resulting as 4838 pg/ml. A second sample was collected from the patient and tested on the customer's e601 analyzer on (b)(6) 2018, resulting with a probnp value of < 5 pg/ml. A third sample was collected from the patient and tested at another hospital on (b)(6) 2018 with an unknown bnp assay, resulting as 2250 pg/ml. This sample was repeated on the customer's e601 analyzer on (b)(6) 2018, resulting with a probnp value of < 5 pg/ml. A fourth sample was collected from the patient on (b)(6) 2018 and provided for investigation, where it was tested on an e602 analyzer and an e411 analyzer. The probnp result from each analyzer was < 5. 0 pg/ml. No adverse events were alleged to have occurred with the patient. The serial number of the customer's e601 analyzer is (b)(4). The serial numbers of the e602 and e411 analyzers used for investigation were asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02104 |
| MDR Report Key | 7649707 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-29 |
| Date of Report | 2018-07-31 |
| Date of Event | 2018-05-21 |
| Date Mfgr Received | 2018-06-12 |
| Date Added to Maude | 2018-06-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-06-29 |
| Model Number | NA |
| Catalog Number | 04842464190 |
| Lot Number | 227748 |
| 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 | 2018-06-29 |