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 2018-03-14 for PROBNP II, N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE 04842464190 manufactured by Roche Diagnostics.
[103025838]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[103025839]
The customer questioned results for 1 patient tested for troponin t hs (high sensitive), elecsys probnp ii immunoassay (probnp ii), elecsys anti-hbc immunoassay, elecsys anti-hbs ii, and elecsys brahms pct on a cobas 8000 e 602 module. Based on the information provided, probnp ii results were discrepant when compared to the abbott architect method. Erroneous results were reported outside of the laboratory. The patient (child, (b)(6)) was admitted to the pediatric care intensive care unit of the hospital on (b)(6) 2017 for "insufficiency acute heart and coma. " the patient had a delay of psychomotor development and was receiving enteral nutrition by gastrostomy. The progression of this condition begins with vomiting after enteral nutrition followed by respiratory distress upon inhalation. On (b)(6) 2018 the troponin t hs result from the e602 module was 249 ng/l at 12:13 a. M. The probnp ii result from the e602 module at the same time was 10,488 ng/l. A new sample was obtained at 5:30 p. M. And the troponin t hs result from the e602 module was 167 ng/l and the probnp ii result was >35,000 ng/l. At 11:15 p. M. The probnp ii result was 34,611 ng/l. It was suspected that the patient had mitochondrial cytopathies and treatment was started. The patient's treatment schedule was pg5%, media lipids, vitamins b1, b8 and b9 and co-enzyme q10. Biotin treatment was also started at 8:00 p. M on (b)(6) 2018. On (b)(6) 2018 a new sample was obtained and additional tests were run. At 5:30 a. M. The patient had a probnp ii result of 40 ng/l on the e602 module. Due to the pro-bnp ii results, the customer suspected a biotin interference. On (b)(6) 2018 the sample from (b)(6) 2018 was tested by the abbott architect method and the bnp result was 153 pg/ml. There were no clinical consequences to the patient. No adverse event occurred due to the device. The e602 module serial number was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00826 |
| MDR Report Key | 7337831 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-14 |
| Date of Report | 2018-04-11 |
| Date of Event | 2018-02-05 |
| Date Mfgr Received | 2018-02-20 |
| Date Added to Maude | 2018-03-14 |
| 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 | 2018-03-14 |
| 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 | 2018-03-14 |