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 2017-05-01 for TINA-QUANT FERRITIN GEN.4 04885317190 manufactured by Roche Diagnostics.
[74164068]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[74164069]
The customer is questioning results for 1 patient tested for ferr4 tina-quant ferritin gen. 4 (ferr4) on a cobas 6000 c (501) module. The patient had ferr4 results "higher than 8000 ng/ml. " the patient was treated with desferrioxamin but the treatment did not appear successful since ferr4 results remained high. The patient? S ferr4 was checked 9 times between (b)(6) 2017 and the results remained between 16,000 ng/ml and 36,000 ng/ml. Refer to attached data for the specific results. No adverse event was reported to have occurred. The c501 module serial number (b)(4). The customer is wondering if the ferr4 assay also recovers ferritin complexed with desferrioxamin. The investigation is ongoing.
Patient Sequence No: 1, Text Type: D, B5
[96878451]
A specific root cause was not identified. Investigations determined that desferrioxamin medication does not interfere with the ferr4 assay.
Patient Sequence No: 1, Text Type: N, H10
[118809832]
The investigation performed an interference study with desferrioxamin and ferr4. No interference was observed up to a concentration of 1440 mg/l of desferrioxamin.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00927 |
| MDR Report Key | 6534052 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-05-01 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-01-18 |
| Date Mfgr Received | 2017-04-12 |
| Date Added to Maude | 2017-05-01 |
| 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 | TINA-QUANT FERRITIN GEN.4 |
| Generic Name | FERRITIN IMMUNOLOGICAL TEST SYSTEM |
| Product Code | DBF |
| Date Received | 2017-05-01 |
| Model Number | NA |
| Catalog Number | 04885317190 |
| Lot Number | 144229 |
| 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 | 2017-05-01 |