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 2016-08-03 for TINA-QUANT FERRITIN GEN.4 04885317190 manufactured by Roche Diagnostics.
[51347507]
This event occurred in (b)(6). Phone number was provided as (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[51347508]
The customer stated that they had questionable results for a total of 12 patient samples tested for tina-quant ferritin gen. 4 (ferr) on a c501 analyzer. Of the 12 samples, 11 had erroneous results that were reported outside of the laboratory. The samples were collected from healthy athletes. The patients were said to not have any medication or diagnosis in common. The 11 patient samples were tested on a c501 analyzer and a beckman analyzer. The results from the c501 analyzer were much higher than the results from the beckman analyzer. The results from the c501 analyzer were reported outside of the laboratory. Refer to the attachment for the patient results. The patients were not adversely affected. The c501 serial number was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
[55222193]
The affected patient samples were provided for investigation. Both the affected patient samples from the customer and 6 other internal patient samples were investigated. During investigations, the ferr c501 results obtained at the customer site could be reproduced. Method comparisons were performed between the c501 analyzer and the reference e601 analyzer method used for investigation and also between the c501 and c501 system used for investigation. The results of the method comparisons were within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01108 |
| MDR Report Key | 5843189 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-03 |
| Date of Report | 2016-09-14 |
| Date of Event | 2016-05-10 |
| Date Mfgr Received | 2016-07-18 |
| Date Added to Maude | 2016-08-03 |
| 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 | 2016-08-03 |
| Model Number | NA |
| Catalog Number | 04885317190 |
| Lot Number | 125038 |
| 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 | 2016-08-03 |