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 2018-12-04 for ELECSYS FERRITIN 03737551190 manufactured by Roche Diagnostics.
[129518430]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[129518431]
The customer questioned results for 1 neonatal patient tested for elecsys ferritin (ferritin) on a cobas 8000 e 602 module. Thirty minutes after being born on (b)(6) 2018, the patient presented with neurological degradation with hypotonia, severe hypoglycemia and hepatocellular insufficiency. At 12:25 a. M. On (b)(6) 2018 the patient was tested for ferritin and the result was 57,907 ug/l suggesting hyperferritinemia. The evening of (b)(6) 2018 biotin treatment was started based on a potential metabolic disease. On (b)(6) 2018 at 5:30 a. M. A new sample was obtained and the ferritin result had decreased to 90 ng/l. The rest of the test results were consistent with the results from (b)(6) 2018. The customer suspects an interference with biotin affecting the ferritin results. There was no allegation that an adverse event occurred. The e602 module serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04621 |
| MDR Report Key | 8129707 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-04 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-09-25 |
| Date Mfgr Received | 2018-11-13 |
| Date Added to Maude | 2018-12-04 |
| 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 | ELECSYS FERRITIN |
| Generic Name | RADIOIMMUNOASSAY (TWO-SITE SOLID PHASE), FERRITIN |
| Product Code | JMG |
| Date Received | 2018-12-04 |
| Model Number | NA |
| Catalog Number | 03737551190 |
| Lot Number | ASKU |
| 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 | 2018-12-04 |