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 2018-10-22 for D-DIMER 04912551190 manufactured by Roche Diagnostics.
[125925153]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[125925154]
The customer received questionable d-dimer gen. 2 results for one patient from cobas 8000 cobas c 502 module serial number (b)(4). The initial result was 10. 29 ug/ml with a data flag. The result with an automatic dilution was 10. 25 ug/ml. On (b)(6) 2018, the customer performed a manual 1:10 dilution and the results were 0. 03 ug/ml and 0. 05 ug/ml. The sample was retested with no dilution and the result was 10. 83 ug/ml. A new sample was collected and the result was 10. 38 ug/ml with a data flag and with an automatic dilution, the result was 10. 83 ug/ml. With a manual 1:6 dilution, the result was 0. 96 ug/ml. The result from a "bcs" analyzer was 197 ng/ml and from an architect analyzer was 132. 49 ng/ml. No erroneous result was reported outside of the laboratory. There was no allegation of an adverse event. The field service representative performed a precision check and confirmed the instrument was working according specification.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03779 |
| MDR Report Key | 7991355 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-22 |
| Date of Report | 2018-12-10 |
| Date of Event | 2018-10-02 |
| Date Mfgr Received | 2018-10-03 |
| Date Added to Maude | 2018-10-22 |
| 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 | 2018-10-22 |
| Model Number | NA |
| Catalog Number | 04912551190 |
| Lot Number | 33132901 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-10-22 |