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 2018-09-12 for D-DIMER 04912551190 manufactured by Roche Diagnostics.
[119950448]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[119950469]
The customer received questionable high d-dimer gen. 2 results for one patient from cobas 6000 c501 module serial number (b)(4) compared to a stago sta analyzer. On (b)(6) 2017, the result from the c501 was 3519 ng/ml and the result from the sta was 1200 ng/ml. On (b)(6) 2018, the result from the c501 was 3360 ng/ml and the result from the sta was 720 ng/ml. It was unclear if the same sample was used for both tests. The results were reported outside of the laboratory. There was no allegation of an adverse event. Calibration and qc results were inconspicuous and were in range, therefore a general issue with the reagent or instrument could be excluded. The investigation did not identify a product problem. The cause of the event could not be determined as sample material was not available for further investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03085 |
| MDR Report Key | 7867956 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-12 |
| Date of Report | 2018-09-12 |
| Date of Event | 2017-10-17 |
| Date Mfgr Received | 2018-08-23 |
| Date Added to Maude | 2018-09-12 |
| 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 | D-DIMER |
| Generic Name | FIBRIN SPLIT PRODUCTS |
| Product Code | GHH |
| Date Received | 2018-09-12 |
| Model Number | NA |
| Catalog Number | 04912551190 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-09-12 |