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 2018-09-07 for TINA-QUANT FERRITIN GEN.4 04885317190 manufactured by Roche Diagnostics.
[119941935]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[119941936]
The customer questioned low results for multiple patients tested for ferr4 tina-quant ferritin gen. 4 (ferr4) on a cobas 6000 c (501) module. The date of event is not clear. The initial low ferr4 results were reported outside of the laboratory where the clinicians questioned them. The customer repeated 14 patient samples by the abbott architect method and all 14 patient samples were discrepant. Refer to attached data for the patient results. There was no allegation that an adverse event occurred. The c501 module serial number was (b)(4). The customer had no calibration or qc issues. It was discovered that the reagent cassette wasn't mixed and to exclude problems with the calibration curve, the customer downloaded the application again and put in a new reagent cassette that was mixed. Afterwards, calibration and qc were good however there were still issues with patient results. The customer performed additional patient comparisons and there were discrepant results between the c501 module and the abbott architect method again. Refer to attached data for these results. The customer stated that each day approximately 25% of the patients they test have extremely low results and when those patients are tested by another method the results are higher. The customer stated the other 75% of patients they test daily receive expected ferr4 results on the c501 module. The customer stated the patient samples affected are of good quality with no hemolysis or foam. The customer is using 13 mm sample tubes with rack adapters. The customer is not having problems with any other tests. The customer performed a precision test with good results. The customer also tested 5 patient samples on a cobas e 411 immunoassay analyzer, a cobas 8000 e 602 module and 2 abbott architect systems. The results between the 2 roche systems were similar and the results between the 2 abbott systems were similar, however, discrepant results were generated between the roche and abbott systems for 3 patient samples. Refer to attached data for these results. Investigations are ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03026 |
| MDR Report Key | 7855496 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-07 |
| Date of Report | 2019-01-28 |
| Date of Event | 2018-07-11 |
| Date Mfgr Received | 2018-07-11 |
| Date Added to Maude | 2018-09-07 |
| 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 | TINA-QUANT FERRITIN GEN.4 |
| Generic Name | FERRITIN IMMUNOLOGICAL TEST SYSTEM |
| Product Code | DBF |
| Date Received | 2018-09-07 |
| Model Number | NA |
| Catalog Number | 04885317190 |
| Lot Number | 29079401 |
| Device Expiration Date | 2019-10-31 |
| 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 | 2018-09-07 |